Replies to post #119748 on Biotech Values

[jbog]

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.

This seems like it will open a new bag of worms. Betterbiosimilar.

I'm wondering how they would treat something like Lilly's humanized egfr versus the chimeric cetuximab?

[jb_118]

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.

A biobetter might be less lucrative than a biosimilar if the former were only marginally better and the latter were substitutable, especially if a biobetter has to generate an entire safety/efficacy package and go through the BLA approval process.

[hptaxis]

Biologics Price Competition and Innovation Act of 2009; Options for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017; Request for Comments. http://www.gpo.gov/fdsys/pkg/FR-2011-05-10/pdf/2011-11348.pdf

[investorgold2002]

"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." "


THIS IS BIG. First time, I have heard that human testing of any kind is not mandatory ..Even Momenta was stating some clinical trial maybe needed on biologics.

[DewDiligence]

LOL re Yahoo’s message-board filtration—references to Janet Woodcock (head of CDER) show up on my screen as “Janet Wood&!#%”.

[DewDiligence]

Biogen Seeks FoB Partner

http://uk.reuters.com/article/2011/05/10/us-summit-biogen-idUKTRE7495AW20110510

›By Toni Clarke
May 11, 2011

(Reuters) - Biogen Idec Inc (BIIB) is discussing with several companies the possibility of forming a partnership to develop generic versions of biotech drugs.

Speaking at the Reuters Health Summit on Tuesday, Chief Executive George Scangos said Biogen, which makes the multiple sclerosis drugs Avonex and Tysabri, is too small to develop a generic biotech business by itself. But he is interested in joining forces with a partner who could sell and market the drugs worldwide.

U.S. regulators are expected to release guidance by the end of the year on what companies need to do to win approval for generic copies of biotech drugs [#msg-62941793]. Generic versions of pills are easy to replicate and eventually sell for one-tenth the price of the branded product. Generic biotech drugs, also known as biosimilars, are expected to sell for a price closer to the original since they are more complex to make and may require clinical trials.

"I've been looking for a way for us to participate in biosimilars without diverting our attention," Scangos said. He expects a biosimilars business could generate north of $1 billion in annual sales.

Scangos said there is a good deal of interest among big pharmaceutical companies and by some biotech companies in forming a partnership. He said Biogen's goal is to leverage the company's manufacturing capability without getting involved in sales and marketing.

STAYING FOCUSED

Scangos said Biogen would be responsible for manufacturing the drugs since it has facilities in the United States and Europe. The partner would handle clinical trials, commercialization, sales and marketing.

"The manufacturing facilities have costs to run them, so the more products you run through them, the more efficient they are," he said. "To set ourselves up commercially could be a big distraction. I'd like a partner to take over that."

The company expects its current round of discussions to be completed by the end of this year.

Since Scangos took over the top job last July, Biogen has cut 17 research and development programs and reallocated resources to those programs it considers most promising. He wants to ensure that the company's entry into biosimilars does not dilute its focus on existing products and its portfolio of experimental drugs. "I've spent a lot of time focusing the company and I don't want us to lose focus now," he said.

A number of generic and branded drugmakers have made biosimilars a priority for future growth, including Teva Pharmaceutical Industries Ltd (TEVA), Novartis AG (NVS), Hospira (HSP) and Merck & Co (MRK).

Scangos said Biogen has already started developing some biosimilars, though he declined to say in which category. Industry observers say one of the first groups of biologic facing generic competition will be rheumatoid arthritis drugs such as Amgen Inc's (AMGN) Enbrel [#msg-59857407].

The company's primary focus, however, will be to develop and launch the products it has in late stage development, including new drugs for hemophilia and multiple sclerosis. Developing biosimilars takes second place. "It's not make-or-break for us," he said. "Our future is in our proprietary products."‹

[tinkershaw]

Dew, that is a literal and open tacit invitation for MNTA to submit their application so that the FDA can have one example to work with to demonstrate this two track path they are talking about.

Directly substitutable vs. branded similars? I don't see how branded similar compete vs. a directly substitutable bioidentical.

What is the process here, will there be direct substitutability or will MNTA and its partner need to market it like a branded?

This screams, "MNTA, we need some regulations and templates, show us how it is done so we can do our job."

Further reduces the risk and increases the reward for MNTA.

Tinker

[jq1234]

Biosimilars two-step


Primer on how FDA plans to review biosimilars for similarity, interchangability

http://www.biocentury.com/biotech-pharma-news/coverstory/2011-05-09/primer-on-how-fda-plans-to-review-biosimilars-for-similarity-interchangability-a1