Amgen pushes agenda for biosimilars on the FDA

Posted under Amgen, Aranesp, biosimilars, Blog, Cancer, Companies, Diagnostics, Enbrel, Epogen, FDA, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Regulatory, Startups, Universities, Videos, Watson Pharmaceuticals by rmcbride

Amgen ($AMGN) has some concerns as the U.S. progresses toward a regulatory pathway for biosimilars development. As one of the largest biotech drugmakers, the company plans to advise the FDA today to adopt standards to guard the safety, supply chain and understanding of the copycat biologics.

The Thousand Oaks, CA-base drugmaker is one of 30 organizations on the docket today for the FDA's informal stakeholder meeting to discuss regulation of biosimilars. Dr. Joseph Miletich, Amgen's senior vice president of R&D, plans to speak on behalf of his company, which is a major player in the biosimilars game. Besides the company's tie-up with Watson to advance cancer biosimilars, Amgen faces competition from knockoff versions of its biologics.

In a release this morning, Amgen revealed that Miletich plans to push for the agency to adopt rules which would put tracking systems in place and distinguish biosimilars from the originals, make clear to doctors and others that biosimilars aren't substitutes for the real thing unless the FDA deems them interchangeable, and keep high quality standards for production of biosimilar products.

Amgen clearly has an interest in protecting the company's franchise of biotech drugs such as Enbrel, Epogen and Aranesp. The company's deal with Watson excludes development of biosimilar versions of Amgen drugs. Yet there are literally hundreds of companies chomping at the bit to develop copycat version of biologics, if not in the U.S., than in emerging markets. And many have already debuted biosimilar products. 

Biogen Idec ($BIIB), Novartis ($NVS) and other large drugmakers are also investing in biosimilars but have an interest in safeguarding their intellectual property for biologics. Biosimilars are much larger and complex molecules than small-molecule generics, and there are major challenges to developing a copycat version of a biologic with the same properties and risk/benefit profile as the original.

"The biosimilar approval pathway is a new initiative in the U.S. with many scientific and administrative challenges and nuances," Miletich said in a statement. "It will be essential for FDA to clearly communicate to all stakeholders what biosimilar products are and are not."

- here's Amgen's release

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Affymax investors bullish on FDA review of Amgen anemia drug rival

Posted under Affymax, Amgen, Aranesp, Blog, Companies, Diagnostics, Epogen, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Facing an expert panel review for peginesatide on Wednesday, FDA staffers gave Affymax ($AFFY) a solid boost in confidence this morning with an agency review that backed the once-monthly anemia treatment as equivalent to Amgen's ($AMGN) blockbuster treatments Epogen and Aranesp. And investors quickly picked up on the positive spin, boosting the biotech's stock more than 25% this morning.

"Data from the clinical program support the efficacy of peginesatide administered once monthly for the treatment of anemia of CKD in dialysis patients," the staffers noted in a detailed review of the data. "The Phase III Dialysis Studies 12 and 14 demonstrated peginesatide could be used to maintain stable Hb levels as successfully as epoetin."

The agency has its reservations about the drug's safety, though, and wants the committee to take a close look at the benefits and risks for patients with chronic kidney disease, "given the safety findings and in light of the prior history with agents that stimulate the erythropoietin receptor." Affymax and its partner Takeda are seeking approval of the drug for CKD patients on dialysis. But as Adam Feuerstein at The Street noted this morning, the FDA's safety concerns appear relatively muted in the report, which helped to further ignite the biotech's share price.

Agency reviews typically contain a sharp focus on any safety or efficacy concerns for a new drug. And investors have been acutely sensitive to some late-stage data on the drug's cardio risks seen in a group of patients. Today they seem to be at least temporarily satisfied that Affymax has taken one more step toward a potential approval for the first direct competitor to Amgen's more frequently administered treatments.

- get the FDA review (.pdf)
- here's the story from The Street
- read the Bloomberg report

Special Report: Amgen - Biotech's Biggest Spenders 2011

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