Biosimilars: Financials 2012 vs. 2008
Curator: Aviva Lev-Ari, PhD, RN
UPDATED on 5/9/2026
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SOURCE
From: IQVIA Institute <ma@iqvia.com>
Reply-To: IQVIA <ma@iqvia.com>
Date: Saturday, May 9, 2026 at 10:02 AM
To: Aviva Lev-Ari <avivalev-ari@alum.berkeley.edu>
Subject: New Report: Biosimilar Sustainability Scorecards for Europe 2026: Overall Summary and Country Scorecards
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For IP and Legal aspects of Biosimilars, go to:
Biosimilars: Intellectual Property Creation and Protection by Pioneer and by Biosimilar Manufacturers
For CMC and Regulatory Affairs of Biosimilars, go to:
Biosimilars: CMC Issues and Regulatory Requirements
http://pharmaceuticalintelligence.com/2012/07/29/biosimilars-cmc-issues-and-regulatory-requirements/
The patent provisions of the Biosimilar Act, 2009 establish demanding and time-sensitive disclosure requirements. ObamaCare upheld by the Supreme Court is a victory for future development of pathways for biosimilar regulatory approval and eventually biosimilar generic drugs.
With the upheld ObamaCare, critical parts of the PPACA constitutional, and with it the BPCIA giving the FDA authority to approve biosimilars.
Had the PPACA been stricken in part or in its entirety, it would have presented obstacles to the BPCIA surviving in its present form. The US government has been critical of the 12-year data exclusivity period for Pioneer Innovators, calling for it to be shortened to 7 years (12 years is favorable to Pioneer Innovators and less favorable for Biosimilar manufacturers). The upheld ObamaCare, PPACA and BPCIA, constitutional, has prevented a multiyear delay in biosimilar approval. Thus, it was the best scenario for the biologics industry.
Thus, projection of Sales for Biosmilars as % of top 100 U.S. Pharmaceutical will receive a special meaning and an expected enhanced market share for 2012 year end and beyond 2012.
Biosimilars are occupying the Following ranking in the U.S. Pharmacuetical Sales – 2012: Top 100 Drugs for Q1 2012 by Sales: 10, 11, 12 13, 15, 24, 27, 29, 33, 35, 39, 57, 58, 62, 65, 70, 72, 74, 90, 98, 99. In addition the following biosimilars did not make the Top 100 list:
Biosimilar Drugs by US Sales – not included in the Top 100 Drug List
Recombinate $2.9 1998 — Antihemophilic Factor VIII (Recombinant) by Baxter 5.7 Billion in 2012
Cerezyme $1.5 1994 — Gaucher disease and Fabrazyme for Fabry disease by Genzyme 200 millions in sales
TYSABRI(R) (natalizumab) revenues were $280 million, in-line with the second quarter of 2011 by Elan and Biogen
NovoSeven $1.4 1999 — Anti-fibrinolytics by Novo Nordisk – $1.5Billion
Synagis $1.3 1998 — Generic Name: palivizumab Anti-virals by AstraZeneca $570 millions
Humulin $1.1 1992 Insulin Human by Eli Lilly $ 1.2 Billion
Kogenate FS $1.1 1993 — octocog alfa Anti-fibrinolytics By Bayer $1.4 billion
U.S. Pharmacuetical Sales – 2012: Top 100 Drugs for Q1 2012 by Sales – Small Molecule Drugs (in green) and Biosimilars (in red)
The following is a list of the top 100 pharmaceutical drugs by retail sales in 2012, listed by U.S. sales value and drug name. Last updated: July 2012 (updated quarterly)
http://www.drugs.com/stats/top100/sales
Source: IMS Health (Midas).
Biosimilars Drugs by US Sales – not included in the Top 100 Drug List
Recombinate $2.9 1998 — Antihemophilic Factor VIII (Recombinant) by Baxter 5.7 Billion in 2012
Cerezyme $1.5 1994 — Gaucher disease and Fabrazyme for Fabry disease by Genzyme 200 millions in sales
TYSABRI(R) (natalizumab) revenues were $280 million, in-line with the second quarter of 2011 by Elan and Biogen
NovoSeven $1.4 1999 — Anti-fibrinolytics by Novo Nordisk – $1.5Billion
Synagis $1.3 1998 — Generic Name: palivizumab Anti-virals by AstraZeneca $570 millions
Humulin $1.1 1992 Insulin Human by Eli Lilly $ 1.2 Billion
Kogenate FS $1.1 1993 — octocog alfa Anti-fibrinolytics By Bayer $1.4 billion
2011 US Sales vs. 2008 US Sales (in Billions) for Top Selling Biologics
Source for 2008 Sales
http://www.tbiweb.org/tbi/file_dir/TBI2009/Bao-lu%20Chen.pdf
Source for 20011, Q1 2012 Sales
http://www.drugs.com/stats/top100/sales
Drug Name, 2008 Sales, Year approved , Indication
[i.e. Drug Name Enbrel, 2008 Sales $8.0B, Year approved 1998 , Indication RA]
Enbrel $8.0 1998 — RA, psoriatic arthritis, or ankylosing spondylitis indication
| Q1 2012 | 12 ( 1) |
$890,135 | 1.92% | 823 | -4.63% |
| Q4 2011 | 11 ( 1) |
$873,343 | 1.67% | 863 | 1.77% |
| Q3 2011 | 12 (1) |
$858,997 | 1.27% | 848 | -2.97% |
| Q2 2011 | 13 (2) |
$848,230 | 3.77% | 874 | 3.19% |
| Q1 2011 | 11 | $817,401 |  |
847 | |
http://www.drugs.com/stats/enbrel
Remicade $7.9 1998 — RA & Chron’s Disease
| Q1 2012 | 11 (2) |
$899,453 | 10.04% | 1,556 | 10.04% |
| Q4 2011 | 13 (3) |
$817,365 | -7.02% | 1,414 | -9.82% |
| Q3 2011 | 10 | $879,054 | 1.52% | 1,568 | 1.03% |
| Q2 2011 | 10 (2) |
$865,903 | 7.61% | 1,552 | 7.11% |
| Q1 2011 | 12 | $804,699 | |
1,449 | |
http://www.drugs.com/stats/remicade
Humira $7.3 2002 — treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis
| Q1 2012 | 10 | $928,124 | 2.50% | 546 | -2.85% |
| Q4 2011 | 10 (1) |
$905,527 | 3.18% | 562 | 2.55% |
| Q3 2011 | 11 (3) |
$877,641 | 3.95% | 548 | 3.01% |
| Q2 2011 | 14 | $844,296 | 6.32% | 532 | 2.31% |
| Q1 2011 | 14 | $794,076 | |
520 | |
http://www.drugs.com/stats/humira
Rituxan $7.3 1997 — cancer medicines to treat non-Hodgkin’s lymphoma or chronic lymphocytic leukemia.
| Q1 2012 | 15 (1) |
$756,875 | -1.91% | 547 | -0.91% |
| Q4 2011 | 14 (2) |
$771,622 | 6.96% | 552 | 4.74% |
| Q3 2011 | 16 | $721,408 | -1.77% | 527 | -1.86% |
| Q2 2011 | 16 (4) |
$734,378 | 7.26% | 537 | 5.09% |
| Q1 2011 | 20 | $684,666 | |
http://www.drugs.com/stats/rituxan
Second Quarter 2012 Highlights: RITUXAN(R) (rituximab) revenues from our unconsolidated joint business arrangement were $285 million for the quarter, an increase of 31% year-over-year. As previously disclosed, during the second quarter of 2011 our share of RITUXAN revenues from unconsolidated joint business was reduced by approximately $50 million to reflect our share of damages and interest that might be awarded in relation to an intermediate decision in Genentech, Inc.’s ongoing arbitration with Hoechst GmbH
Herceptin $5.7 1998 — treat metastatic breast cancer that has progressed after treatment with other chemotherapy
| Q1 2012 | 33 | $425,687 | -0.06% | 155 | |
| Q4 2011 | 33 (2) |
$425,931 | 7.61% | 155 | 4.73% |
| Q3 2011 | 31 (1) |
$395,804 | -0.64% | 148 | -0.67% |
| Q2 2011 | 32 (4) |
$398,348 | 3.62% | 149 | 1.36% |
| Q1 2011 | 36 | $384,428 | |
147 | |
http://www.drugs.com/stats/herceptin
Lantus $5.1 2000 — long-acting form of the hormone insulin.
| Q1 2012 | 29 (5) |
$448,388 | 9.81% | 3,737 | 7.32% |
| Q4 2011 | 34 | $408,336 | 8.54% | 3,482 | 7.07% |
| Q3 2011 | 34 (2) |
$376,208 | 4.53% | 3,252 | 6.00% |
| Q2 2011 | 36 (5) |
$359,907 | 7.80% | 3,068 | 8.30% |
| Q1 2011 | 41 | $333,878 | |
2,833 | |
http://www.drugs.com/stats/lantus-solostar
Epogen/Procrit $5.1 1989 — Anemia, low RBC
Worldwide, sales of the two drugs – sold under the brand names Epogen, Procrit and Aranesp – exceeded $9 billion in 2005 for Amgen and Johnson & Johnson, their makers. Johnson & Johnson, which sells epoetin under the brand names Procrit in the United States and Eprex everywhere else, reported sales of $2.4 billion in the first nine months of 2006, down slightly from 2005.
09/24/2010 – Drug-makers Amgen (AMGN) and Johnson & Johnson (JNJ) are voluntarily recalling two brandsof an injectable anemia medication because vials containing the drug may have tiny glass flakes. The drug, Epoetin alfa, is marketed under the brand names Epogen and Procrit.Known as lamellae, the glass fragments are created by the interaction of the drug with glass vials during storage, Amgen said in a statement announcing the recall. The recall is being conducted in cooperation with the Food and Drug Administration, Amgen said.Latest study shows anemia drugs Epogen, Aranesp and Procrit cause strokes, says FDA
Posted on January 7, 2010
Anemia drugs sold by Amgen and Johnson & Johnson have been reported to cause strokes when prescribed in high doses, according to an article from the FDA, recently published in the The New England Journal of Medicine. The law firm of Aylstock, Witkin, Kreis & Overholtz is investigating the FDA’s recent announcement.
The FDA commentary said the latest study and previous studies “raise major concerns” about the use of these drugs to treat anemia caused by kidney disease. The drugs are also used to treat anemia caused by chemotherapy. Studies over the past several years have revealed a link between the drugs and heart attacks, strokes, and other problems.
Amgen’s anemia drugs include Epogen and Aranesp. Johnson & Johnson sells anemia drug Procrit, which is produced by Amgen. The drugs are designed to raise red blood cell levels, to promote delivery of oxygen to body tissues.
Epogen / Procrit / Aranesp: The July 2012 News Report Which Tells Story Of Big Pharma Profits Over Patient Safety And Drug Efficacy
Once The FDA Started Paying Attention The Writing On The Wall Became Apparent, Albeit Too Late For Some
(Posted by Tom Lamb at DrugInjuryWatch.com)
This lengthy and well-presented news report, “Anemia drugs made billions, but at what cost?”, written by Peter Whoriskey and published July 19, 2012 by The Washington Post (free registration required), is a must-read for anyone with a concern or interest in how larger pharmaceutical companies might put corporate profits ahead of patient safety and drug efficacy.
Here is an excerpt from this Washington Post article which will give you a sense of what went on that, in hindsight, is so disturbing:
For years, a trio of anemia drugs known as Epogen, Procrit and Aranesp ranked among the best-selling prescription drugs in the United States, generating more than $8 billion a year for two companies, Amgen and Johnson & Johnson. Even compared with other pharmaceutical successes, they were superstars. For several years, Epogen ranked as the single costliest medicine under Medicare: U.S. taxpayers put up as much as $3 billion a year for the drugs.
The trouble, as a growing body of research has shown, is that for about two decades, the benefits of the drug — including “life satisfaction and happiness” according to the FDA-approved label — were wildly overstated, and potentially lethal side effects, such as cancer and strokes, were overlooked.
Last year, Medicare researchers issued an 84-page study declaring that among most kidney patients, the original and largest market for the drugs, there was no solid evidence that they made people feel better, improved their survival or had any “clinical benefit” besides elevating a statistic for red blood cell count.
As for some of the key events which led up to this revelation of sorts, we start with a June 24, 2011 FDA press release, “FDA modifies dosing recommendations for Erythropoiesis-Stimulating Agents — Cites increased risk of cardiovascular events when used to treat chronic kidney disease”, which included the following:
The U.S. Food and Drug Administration today recommended more conservative dosing guidelines for Erythropoiesis-Stimulating Agents (ESAs) when used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular events such as stroke, thrombosis, and death….
Procrit — (epoetin alfa) is a man-made form of a protein that helps your body produce red blood cells
| Q1 2012 | 58 ( 3) |
$264,190 | -2.13% | 295 | -4.22% |
| Q4 2011 | 55 (2) |
$269,937 | 3.58% | 308 | 3.01% |
| Q3 2011 | 53 (12) |
$260,610 | -21.61% | 299 | -21.32% |
| Q2 2011 | 41 ( 7) |
$332,466 | 7.04% | 380 | 5.56% |
| Q1 2011 | 48 | $310,606 |  |
360 | |
http://www.drugs.com/stats/procrit
Epogen — (epoetin alfa) is a man-made form of a protein that helps your body produce red blood cells
| Q1 2012 | 27 (7) |
$489,570 | -24.54% | 555 | -17.04% |
| Q4 2011 | 20 (2) |
$648,794 | 4.67% | 669 | 3.40% |
| Q3 2011 | 22 (2) |
$619,828 | -13.96% | 647 | -18.41% |
| Q2 2011 | 20 (1) |
$720,376 | 3.32% | 793 | 4.48% |
| Q1 2011 | 19 | $697,224 | |
759 | |
http://www.drugs.com/stats/epogen
Neulasta $4.2 2002 — used to prevent neutropenia, a lack of certain white blood cells caused by receiving chemotherapy. stimulates the bone marrow and promotes the growth of white blood cells called neutrophils
| Q1 2012 | 13 (1) |
$849,971 | 3.33% | 331 | 1.53% |
| Q4 2011 | 12 (2) |
$822,578 | 4.59% | 326 | 3.49% |
| Q3 2011 | 14 (1) |
$786,464 | -3.86% | 315 | -5.69% |
| Q2 2011 | 15 | $818,068 | 4.04% | 334 | 3.41% |
| Q1 2011 | 15 | $786,288 | |
323 |
http://www.drugs.com/stats/neulasta
Novolog $3.7 2000 — Insulin aspart is a fast-acting form of insulin. NovoLog is used to treat type 1 (insulin-dependent) diabetes in adults and children who are at least 2 years old. It is usually given together with a long-acting insulin.
| Q1 2012 | 57 (6) |
$266,305 | 5.67% | 2,980 | 3.72% |
| Q4 2011 | 63 (3) |
$252,015 | 0.97% | 2,873 | -0.48% |
| Q3 2011 | 60 (1) |
$249,591 | -0.96% | 2,887 | -2.66% |
| Q2 2011 | 61 (5) |
$252,010 | 3.16% | 2,966 | -0.70% |
| Q1 2011 | 66 | $244,297 | |
2,987 | |
http://www.drugs.com/stats/novolog
Erbitux $3.6 2004 — used to treat cancers of the colon and rectum. It is also used to treat head and neck cancer.
| Q1 2012 | 99 (2) |
$171,513 | 2.30% | 266 | 3.91% |
| Q4 2011 | 97 (7) |
$167,657 | -0.15% | 256 | 0.79% |
| Q3 2011 | 90 (3) |
$167,909 | -2.48% | 254 | -1.93% |
| Q2 2011 | 93 (2) |
$172,185 | -0.89% | 259 | -0.38% |
| Q1 2011 | 95 | $173,735 | |
260 | |
http://www.drugs.com/stats/erbitux
Aranesp $3.2 2001 — Anemia, low RBC, (darbepoetin alfa) is a man-made form of a protein that helps your body produce red blood cells.
| Q1 2012 | 72 (6) |
$231,643 | -5.86% | 293 | -7.86% |
| Q4 2011 | 66 (15) |
$246,056 | -6.07% | 318 | -3.64% |
| Q3 2011 | 51 (3) |
$261,967 | -10.25% | 330 | -11.29% |
| Q2 2011 | 48 (3) |
$291,873 | -1.03% | 372 | -1.33% |
| Q1 2011 | 51 | $294,912 | |
377 | |
http://www.drugs.com/stats/aranesp
| The article reports on the decline of worldwide sales of Aranesp drug from Thousand Oaks, California-based Amgen Inc. as of the second quarter of 2007. According to Amgen, the 10% decrease of Aranesp worldwide sales was due to the reimbursement issues related to the anemia drug and the drop of U.S. demand for drug, in which the U.S. Aranesp reported sales in the second quarter of 2007 was only $578 million from $713 million in 2006. |
http://connection.ebscohost.com/c/articles/26375335/amgen-posts-lower-aranesp-sales
1/24/2011, Amgen boosts prices to offset Aranesp sales
Amgen is hiking prices to make up for the shrinking sales volume of its anemia drug Aranesp. Bloomberg reports that Amgen raised the price tag on Aranesp itself by 4.4 percent, but also marked up the white-blood-cell-boosting meds Neulasta and Neupogen by 2.9 percent.
http://www.fiercepharma.com/story/amgen-boosts-prices-offset-aranesp-sales/2011-01-24
Recombinate $2.9 1998 — Antihemophilic Factor VIII (Recombinant)
BioScience core franchises include: Hemophilia, Biotherapeutics, BioSurgery and Vaccines. BioScience products represent approximately 45 percent of Baxter’s annual sales, totaling $5.7 billion in 2010.
2007 Outlook – Sales within Baxter’s BioScience business totaled $1.2 billion, an increase of 18 percent from the same period last year. This growth was driven by record sales of ADVATE, Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM) for the treatment of hemophilia A, antibody therapy products, including GAMMAGARD LIQUID(TM) [Immune Globulin Intravenous (Human)] (IVIG) 10% Solution for the treatment of primary immunodeficiencies, specialty plasma therapeutics and biosurgery products. Medication Delivery sales increased 7 percent to $1.0 billion, with increased sales of infusion systems, intraveneous solutions and parenteral nutrition products, along with accelerated growth in the company’s drug delivery business. Renal sales increased 6 percent to $537 million reflecting accelerating gains in peritoneal dialysis patients globally.
Lucentis $2.7 2006 intraocular injection. (ranibizumab injection) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A).
| Date Range | Sales Rank | Sales ($000) | Units (000) | ||
|---|---|---|---|---|---|
| Q1 2012 | 35 (5) |
$409,547 | -6.89% | 224 | -5.88% |
| Q4 2011 | 30 (2) |
$439,867 | 2.44% | 238 | 2.59% |
| Q3 2011 | 28 (2) |
$429,393 | 1.13% | 232 | 0.87% |
| Q2 2011 | 30 (3) |
$424,611 | 0.95% | 230 | 1.32% |
| Q1 2011 | 33 | $420,635 | |
227 | |
http://www.drugs.com/stats/lucentis
http://www.gene.com/gene/about/ir/historical/product-sales/lucentis.html
Lucentis brought in $1.7 billion for Roche last year, according to data compiled by Bloomberg.Alimera Sciences Inc. (ALIM), based in Alpharetta, Georgia, and Psivida Corp. (PSDV) also are developing a diabetic macular edema treatment known as Iluvien. The FDA has twice rejected Iluvien, most recently in November.
The FDA pooled results from two Roche clinical trials and found 39 percent of patients who used the 0.3 milligram dose were able to read three additional lines of letters on an eye chart after two years compared to 41 percent who had the same effect on the 0.5 milligram dose, according to an FDA staff report released July 24.
Genentech recommended approval of the 0.3 milligram dose in its application to the FDA since there isn’t evidence of additional benefit of the higher dose, Terence Hurley, a spokesman for the company, said in an e-mail.
Patients who received the monthly injection also were significantly more likely than those who received fake doses of the drug to achieve 20/40 vision, enough eyesight to drive.
Avonex $2.6 1996 — Multiple Sclerosis, a form of protein called beta interferon that occurs naturally in the body. Interferons help the body fight viral infections. Avonex is used to treat patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability. This medication will not cure MS, it will only decrease the frequency of relapse symptoms.
| Q1 2012 | 39 (1) |
$388,623 | 2.22% | 130 | -3.70% |
| Q4 2011 | 38 (5) |
$380,189 | 0.19% | 135 | -2.17% |
| Q3 2011 | 33 | $379,457 | -0.05% | 138 | -1.43% |
| Q2 2011 | 33 (4) |
$379,639 | 2.45% | 140 | -1.41% |
| Q1 2011 | 37 | $370,570 | |
142 | |
http://www.drugs.com/stats/avonex
Second-quarter net income surged 34 percent to $386.8 million, or $1.61 a share, from $288 million, or $1.18, a year earlier, the Weston, Massachusetts-based company said today in a statement. Earnings excluding some items of $1.82 topped by 26 cents the average of 21 analysts’ estimates (BIIB) compiled by Bloomberg. Revenue beat estimates by about $90 million.
Biogen said profit this year is expected to be more than $6.20 a share, 5 cents higher than its May 1 forecast (BIIB). The company has been increasing sales of Avonex, Rituxan and Tysabri, another MS therapy, while developing new medicines to introduce to the market.
Novolin $2.5 1991 — Novolin R (insulin regular) is a short-acting form of human insulin, Diabetes, Type 1 Type 2
| Date Range | Sales Rank | Sales ($000) | Units (000) | ||
|---|---|---|---|---|---|
| Q1 2012 | 74 (2) |
$227,228 | 8.96% | 2,489 | 13.81% |
| Q4 2011 | 76 (4) |
$208,552 | 10.19% | 2,187 | 6.73% |
| Q3 2011 | 80 (6) |
$189,267 | 4.15% | 2,049 | 4.92% |
| Q2 2011 | 86 (7) |
$181,733 | 3.71% | 1,953 | 29.60% |
| Q1 2011 | 93 | $175,235 | |
1,507 | |
http://www.drugs.com/stats/novolog-flexpen
Novo Nordisk launches iPhone app Posted 17th September 2010, 15:11:54
Novo Dose provides product-specific data for the company’s insulin analog agents Levemir (insulin detemir), NovoLog (insulin aspart) and NovoLog Mix (insulin aspart protamine/insulin aspart injectable).
Combined sales of the three medications increased by 24% last year, feeding a double-digit growth in Novo Nordisk sales and profits.
Novo Dose, the second diabetes app created by the industry, tells professionals when and how to dose the drugs, how to titrate and provides information on the blood glucose goals of patients.
Commenting on the new technology, Anup Kumar Sabharwal, an endocrinologist at the University of Miami Clinics’ Diabetes Research Institute, said: “This is where modern medicine is headed.”
Humalog $2.2 1996 Humalog is used to treat type 1 (insulin-dependent) diabetes in adults. Insulin lispro is a fast-acting form of insulin. It is usually given together with another long-acting insulin. It works by lowering levels of glucose in the blood. Humalog is also used together with oral (taken by mouth) medications to treat type 2 (non insulin-dependent) diabetes in adults.
| Q1 2012 | 65 | $244,587 | -2.70% | 2,570 | -3.85% |
| Q4 2011 | 65 (2) |
$251,367 | 3.78% | 2,673 | 2.81% |
| Q3 2011 | 63 (4) |
$242,208 | -0.75% | 2,600 | -1.78% |
| Q2 2011 | 67 (5) |
$244,050 | 4.83% | 2,647 | 1.15% |
| Q1 2011 | 72 | $232,809 | |
2,617 | |
http://www.drugs.com/stats/humalog
Pegasys $2.0 2002 — (peginterferon alfa-2a) is made from human proteins that help the body fight viral infections. Pegasys is used to treat chronic hepatitis B or C. It is often used together with another medication called ribavirin (Copegus, Rebetol, RibaPak, Ribasphere, RibaTab).
| Q1 2012 | 90 (1) |
$181,693 | 3.92% | 87 | 3.57% |
| Q4 2011 | 91 ( ) |
$174,833 | |
84 | |
http://www.drugs.com/stats/pegasys
Rebif $1.7 2002 — (interferon beta-1a) is a protein identical to one found in the body. Interferon beta-1a is made from human proteins. Interferons help the body fight viral infections. Rebif is used to treat relapsing multiple sclerosis (MS). This medication will not cure MS, it will only decrease the frequency of relapse symptoms.
| Q1 2012 | 62 (1) |
$258,088 | -0.21% | 540 | -9.09% |
| Q4 2011 | 61 (7) |
$258,643 | 0.43% | 594 | -0.34% |
| Q3 2011 | 54 (5) |
$257,535 | 1.48% | 596 | -1.49% |
| Q2 2011 | 59 (2) |
$253,780 | 0.25% | 605 | -0.66% |
| Q1 2011 | 61 | $253,143 | |
609 | |
http://www.drugs.com/stats/rebif
Cerezyme $1.5 1994 — Gaucher disease and Fabrazyme for Fabry disease.
Last year Genzyme was forced to temporarily close its manufacturing plant in Boston due to a viral contamination. The interruption lead to shortages of two key drugs: Cerezyme for Gaucher disease and Fabrazyme for Fabry disease.
That crisis sent the company’s stock price plummeting from nearly $84 in 2008 to a low earlier this year of $45.39. Sanofi’s offer to acquire the company for $18.5 billion, or $69 a share — along with a 14 percent rise in the NYSE Arca Biotech Index since late July — have helped the shares rebound.
But Genzyme is now on a mission to prove to shareholders that it is worth more than Sanofi is offering, and executives told investors on a conference call that the third quarter marks the beginning of its financial turnaround.
Third-quarter sales of Cerezyme, the company’s top drug, rose to $179.8 million from $93.6 million a year earlier, beating analysts’ average forecast of $175 million.
“In the third quarter we saw our financial recovery start to take effect, and we expect that this will accelerate during the fourth quarter as Cerezyme patients are able to return to normal dosing levels and we begin to increase shipments of Fabrazyme,” Genzyme CEO Henri Termeer said in a statement.
| Product | Cerezyme | ||
| 2009 | 2010 | 2011 | |
| Total | 793 | 720 | 885 |
| Ann. Growth Total | -9% | 23% |
Tysabri $1.4 2004 — Multiple Sclerosis by Elan and Biogen
Global in-market sales of TYSABRI in the second quarter of 2012 were $395 million, an increase of 2% over the second quarter of 2011. The total was comprised of $211 million in U.S. sales and $184 million in sales outside the U.S.
Elan derives its revenue almost exclusively from Tysabri and it reported total sales for the three months to June 30 of $288 million, up 6 percent on a year ago once sales from its since-divested drug delivery business are omitted.
That compared to the $299 million forecast by four analysts surveyed by Reuters and was driven by in-market sales of Tysabri that rose 2 percent year-on-year to $395 million, also shy of the $419 million expected by analysts.
Biogen, which detailed the sales numbers when it reported second quarter results on Tuesday, attributed the softer-than-expected Tysabri sales to a dispute with the Italian government over pricing.
The number of patients on Tysabri rose 4 percent to 69,100, maintaining Elan and Biogen’s 10 to 12 percent share of the MS drug market in the face of competition from Swiss drugmaker Novartis AG’s Gilenya treatment, the first multiple sclerosis pill to come on the market.
The average addition of 185 new patients per week was the highest quarterly run-rate since the fourth quarter of 2009.
http://in.reuters.com/article/2012/07/25/elan-idINL6E8IP1VV20120725
NovoSeven $1.4 1999 — Anti-fibrinolytics by Novo Nordisk —
| Generic Name: | eptacog alfa |
| Product | NovoSeven | ||
| 2009 | 2010 | 2011 | |
| Total | 1,324 | 1,431 | 1,559 |
| Ann. Growth Total | 8% | 9% |
Synagis $1.3 1998 — Generic Name: palivizumab Anti-virals by AstraZeneca
| Product | Synagis | ||
| 2009 | 2010 | 2011 | |
| Total | 1,042 | 906 | 570 |
| Ann. Growth Total | -13% | -37% |
Neupogen $1.3 1991 — (filgrastim) is a man-made form of a protein that stimulates the growth of whiteblood cells in your body. White blood cells help your body fight against infection. Neupogen is used to treat neutropenia, a lack of certain white blood cells caused by cancer,bone marrow transplant, receiving chemotherapy, or by other conditions.
| Q1 2012 | 70 | $238,427 | 0.06% | 170 | -2.86% |
| Q4 2011 | 70 (5) |
$238,289 | 0.16% | 175 | 10.76% |
| Q3 2011 | 65 (5) |
$237,915 | 0.69% | 158 | 0.64% |
| Q2 2011 | 70 (4) |
$236,294 | 2.51% | 157 | 0.64% |
| Q1 2011 | 74 | $230,515 | |
156 | |
http://www.drugs.com/stats/neupogen
Betaseron $1.2 1993 — (interferon) is made from human proteins. Interferons help the body fight viral infections. Betaseron is used to treat relapsing multiple sclerosis (MS). Betaseron will not cure MS, it will only decrease the frequency of relapse symptoms.
| Q1 2012 | 98 (1) |
$172,143 | 2.93% | 67 | -10.67% |
| Q4 2011 | 99 (12) |
$167,236 | -3.76% | 75 | -5.06% |
| Q3 2011 | 87 (2) |
$173,769 | -2.89% | 79 | -2.47% |
| Q2 2011 | 89 (4) |
$178,938 | -2.17% | 81 | -7.95% |
| Q1 2011 | 85 | $182,908 | |
88 | |
http://www.drugs.com/stats/betaseron
Humulin $1.1 1992 Insulin Human by Eli Lilly
| Product | Humulin R | ||
| 2009 | 2010 | 2011 | |
| Total | 1,022 | 1,089 | 1,249 |
| Ann. Growth Total | 7% | 15% |
Kogenate FS $1.1 1993 — octocog alfa Anti-fibrinolytics By Bayer
| Product | Kogenate | ||
| 2009 | 2010 | 2011 | |
| Total | 1,238 | 1,332 | 1,496 |
| Ann. Growth Total | 8% | 12% |
Conclusion
Biosimilars are defined as biological products similar, but not identical, to the reference biological products that are submitted for separate marketing approval following patent expiration of the reference biological products. As one of the ICH members, the US needs to catch up with the EU and Japan as those two countries have already issued regulatory guidelines for biosimilars.
Once Congress establishes a legal framework, FDA is expected to set up a biosimilar approval pathway which will be similar to those in the EU and Japan and harmonized under ICH. The biosimilar will need a full CMC development package plus demonstration of comparable quality attributes and comparable efficacy and safety to the innovator’s product. Table 5 provides a comparison summary between small-molecule generics and biosimilars. It will take a much bigger effort to develop a biosimilar than a generic drug. Automatic substitution between the innovator product and a biosimilar is not appropriate as a biosimilar is not a generic version of the innovator product and is approved based on comparability to the innovator product.
REFERENCES
http://www.wolfgreenfield.com/files/2426_biosimilars_2_final_pdf.pdf
2012pharmaceutical
sjwilliamspa