Replies to post #119060 on Biotech Values

[dav1234]

wow, interesting, so clarity on biologics may come sooner than later

[DewDiligence]

It’s excellent news for MNTA investors that an FDA staffer cites MNTA’s generic Lovenox as the impetus for the FDA’s going “one step further” than the EMA is enabling biogenerics. This is consistent with Craig Wheeler’s claim that the FDA’s requirements for generic Lovenox were essentially crafted by MNTA itself.

[pcrutch]

that's pretty great news. maybe it bodes well for the Copaxone ANDA as well. i mean, if they were that impressed by the Lovenox application, i am sure $MNTA brought their A+ game to Copaxone as well. thanks for the article.

[DewDiligence]

Re: FDA pathway for FoB’s

Further to Dr. Behrman’s talk mentioned in #msg-62559655:

Dr. Behrman explained that “analytics are the fundamentals.” This means that companies should use analytical techniques to characterize their biosimilar and try to prove that it's bioequivalent to the brand. Once FDA understands the analytics, they will determine “the extent of animal and human testing that will be necessary” on a case-by-case basis.

This echoes what Craig Wheeler has said on various occasions—compared to analytics, a clinical trial is a blunt instrument and will not be the main evidence to establish FDA approvability of an FoB.

In most cases, a clinical trial involving switching patients between the brand and the FoB will be required for an FoB to receive interchangeable status with its branded counterpart, but the switching trial can presumably be conducted after FDA approval with non-interchangeable status has been granted.

The quoted passage above comes from a sell-side research report. Sorry, I do not have a link.

[DewDiligence]

FDA Reiterates Commitment to Issue FoB Guidance in 2011

[Can you imagine if Amphastar were a prospective player in the FoB arena? Based on this write-up, they would already be screaming that Janet Woodcock is biased in favor of MNTA. See #msg-49883723, #msg-48581353, #msg-26837144, #msg-62559655, #msg-62631138, and #msg-62805964 for related info.]

http://www.reuters.com/article/2011/05/09/us-summit-fda-biosimilars-idUSTRE74858V20110509

›May 10, 2011
By Deena Beasley

NEW YORK (Reuters) - The Food and Drug Administration expects to issue this year general guidance for companies seeking to market generic versions of biotechnology drugs, a top agency official said on Monday.

The complex drugs, produced through biological processes that generally involve recombinant DNA technologies, are known as biosimilars. Ranging from relatively simple molecules like insulin to complex anti-cancer antibody drugs, biosimilars have individual characteristics that will need specific regulatory requirements, Janet Woodcock, head of FDA's Center for Drug Evaluation and Research, said on Monday.

Human testing will not be an across-the-board requirement. "It depends on how confident you can be of the absolute sameness to the innovator product," Woodcock said. "There's a spectrum...some will get much closer than others in your ability to characterize them."

Many drugmakers are seeing potential in the business of producing copycat versions of expensive biotechnology drugs as the FDA closes in on new rules for their approval. Several companies are already marketing in Europe versions of anemia drug erythropoietin, which is sold by Amgen Inc (AMGN) under the brand name Epogen.

The worldwide market for copies of biotech medicines will grow to $3.7 billion by 2015 from just $243 million in 2010, according to a recent report from market analysis firm Datamonitor [#msg-61414941].

"We are meeting with companies individually right now and giving them advice on their programs," Woodcock said, noting that potential players include traditional generic drugmakers, makers of branded biotech drugs and companies not previously involved in the U.S. market.

Under the U.S. healthcare law passed last year, brand-name biologic drugs -- which can have annual price tags in the tens of thousands of dollars -- were granted a 12-year period of market exclusivity, after which generic versions can be sold [see chart in #msg-60342122].

The FDA on Monday asked for input on its program for collecting fees from drug companies looking to market biosimilars.

Woodcock said that if a biotech company develops a longer-lasting version of a drug, or otherwise alters an existing molecule to improve efficacy of safety, it would be considered a new molecule, with a new 12-year exclusivity.

"We are very interested in providing competition where we have a mandate," she said.

With traditional pharmaceuticals, the introduction of multiple products and more generic competition can dramatically lower prices, but biosimilars are harder to manufacture, so the price savings won't be as steep, the FDA drugs chief said.

Woodcock said the FDA has learned much from the evolving market in Europe, including the need to be able to track down the specific manufacturer of a biosimilar drug. She said the U.S. agency has yet to receive any actual biosimilar applications, but there is a great deal of industry interest.

"We are open for business right now," Woodcock said.‹

[DewDiligence]

How much FoB activity has occurred to date in the US?

http://blog.pharmtech.com/2012/02/03/fda-gives-biosimilars-update

To date, there have been 35 Pre-IND meeting requests for proposed biosimilars to 11 reference products. 21 PRE IND sponsor meetings held, and 9 INDs received.