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U.S. FDA guidance on biosimilars may be imminent
September 23, 2011 / 8:36 PM / in 6 years

U.S. FDA guidance on biosimilars may be imminent

NEW YORK (Reuters) - The U.S. Food and Drug Administration appears to be on the verge of issuing long-awaiting guidelines for the development of generic versions of complex biotechnology medicines.

The FDA still plans to release the guidance by the end of the year but the agency’s top drug official, Janet Woodcock, has indicated it could come “as early as the next few weeks, maybe even days,” Janice Soreth, deputy director of the agency’s Europe office in London, said on Friday.

Europe is ahead of the United States on this front, having already approved cheaper copies of some biotech medicines.

The U.S. agency has completed work on the guidance and expects to release it “promptly,” Woodcock said in an interview, according to the biotechnology trade publisher BioCentury.

The agency has also reached a “tentative agreement” with industry representatives over user fees companies would pay to support the biosimilar approval process, according to minutes of a meeting between FDA and the industry posted on FDA’s website.

Drugmakers, investors and others are eager to gain more insight for the approval process for cheaper versions of biotech drugs, known as “biosimilars” -- a potentially multibillion-dollar market.

Soreth made her comments during a biosimilars panel at Windhover’s Pharmaceutical Strategic Alliances Conference, held in New York.

She said an article written by FDA officials in last month’s New England Journal of Medicine was an indicator of what the guidance might look like. Agency officials said in the article that approval for biosimilars “will require a new paradigm of sponsor-FDA interactions,” involving analysis of much more data than traditional generics.

Unlike conventional, easy to replicate, chemical-based drug compounds, biotech drugs are derived from living organisms, such as proteins, and often produced using recombinant DNA technologies.

Agreement on a pathway for producing cheaper versions of biotech drugs -- which treat diseases such as cancer, rheumatoid arthritis and multiple sclerosis -- has been far more difficult than for traditional pills and capsules because their complex manufacturing process does not lend itself to production of exact copies.

Making biotech copies is also expected to be more costly, as manufacturers must conduct extra clinical trials to show the new version is as good as the old one.

Soreth said the FDA has received about two dozen meeting requests for proposed biosimilar products, involving potential versions of nine or 10 brand biotech drugs, or “reference” products.


The potential players in the burgeoning market include traditional generic drugmakers, such as Novartis’ Sandoz division, as well as large pharmaceutical companies like Pfizer and Merck -- all of whom participated in the panel on Friday.

Some traditional biotechnology companies, such as Biogen Idec and Amgen Inc , have also expressed an interest in manufacturing biosimilars at some point.

As the market develops for biosimilars, it remains unclear to what extent it will mimic the market for pills -- in which generics of widely sold drugs are substituted for brands at pharmacies and are sold at 90 percent discounts.

The biosimilar process, at least initially, may not allow such direct substitutions or involve such hefty discounts. Indeed, panelists on Friday agreed the discounts thus far have been about 20 percent to 40 percent.

Michael Kamarck, president of Merck BioVentures, said the European experience with biosimilars has demonstrated the products will demand marketing and other support similar to that required for brand products.

Doctors and patients may demand more evidence for these products, beyond just FDA approval, before using them, Kamarck said.

“In small molecule generics, you get these products licensed and registered and you’re done. It’s just the beginning for these products,” Kamarck said.

“We are assuming this is a branded business for the next at least four or five years,” he said.

But Jim Roach, chief medical officer of Momenta Pharmaceuticals Inc , said the pressure brought by health insurers and other healthcare payers to lower drug costs may ultimately prompt increased use of biosimilars, should they win approval.

“That pressure will only continue to increase over time,” Roach said.

“To the extent you can convince regulators that your product is highly similar and perhaps indistinguishable and potentially interchangeable, I think the products will be taken up quite well.”

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