Replies to post #93667 on Biotech Values

[DewDiligence]

New Survey: When Will FDA Approve First Biosimilar/Biogeneric?

Definitions for this survey:

• A biosimilar is a non-substitutable biologic drug whose approval is based, in part, on the safety and efficacy dossier of the corresponding branded drug.

• A biogeneric is a biologic that is fully substitutable by a pharmacist or hospital formulary for the corresponding branded drug.

(Please see #msg-48581353 for provisions of the recently enacted law that empowers the FDA to approve biosimilars and biogenerics.)


Q1: When will FDA approve the first biosimilar?
a) 2010
b) 2011
c) 2012 or later
d) Never


Q2: When will FDA approve the first biogeneric?
a) 2010
b) 2011
c) 2012 or later
d) Never


To vote, go to
http://www.investorshub.com/boards/board_surveymenu.asp?board_id=1418
and select survey #132.

[DewDiligence]

WSJ Profiles Private Companies in the ‘Biobetter’ Arena

http://blogs.wsj.com/venturecapital/2010/08/10/a-race-to-develop-better-performing-biopharmaceuticals

›By Brian Gormley
August 10, 2010

Congress’s approval of a regulatory pathway for “biosimilars” has focused attention on the potential to maker cheaper but nearly identical versions of existing biopharmaceuticals. But to some venture-backed start-ups, the bigger opportunity is “bio-betters.”

Biosimilars are the closest thing possible to generic versions of biotech drugs. Unlike conventional small-molecule drugs made through chemical synthesis, large-molecule, biopharmaceuticals are produced in living organisms – such as animals or bacteria – and cannot be copied exactly.

Conventional, small-molecule generics pass through an abbreviated regulatory pathway to approval, but until recently there was no corresponding process for biosimilars. That changed in March with the passage of the Patient Protection and Affordable Care Act.

One venture-backed company that seeks to capitalize on the biosimilar opportunity is Itero Biopharmaceuticals Inc., of San Mateo, Calif. In July it licensed its preclinical-stage, biosimilar version of recombinant follicle stimulating hormone, a treatment for female infertility, to publicly held Watson Pharmaceuticals Inc.

But Itero’s chief executive, V. Bryan Lawlis, said the company’s next product will likely be a bio-better – a drug that is in the same class as an existing biopharmaceutical but is not identical. While a biosimilar should perform as well as the original, a bio-better is expected to have certain advantages, such as improved safety and efficacy.

Unlike biosimilars, there’s no abbreviated regulatory route for bio-betters. But because they follow in the footsteps of a drug that has already been shown to be a therapeutic and commercial success, the risk of failure is expected to be lower than with most new drugs.

Itero hasn’t determined what its next product will be, but Lawlis said the company’s eventual goal is to be able launch its own drugs. Panorama Capital, SV Life Sciences and VenturEast are its venture backers.

Femta Pharmaceuticals Inc., whose investors include Latterell Venture Partners and Biotech Investment Group, is developing what it hopes will be a fast-follower to Actemra, a new treatment from Genentech Inc. aimed at adults with moderately to severely active rheumatoid arthritis.

Actemra is an antibody, dosed intravenously, that inhibits the interleukin-6 receptor. Femta’s Fm101, by contrast, is an antibody that blocks IL-6 itself. IL-6 levels do not fluctuate as much as levels of the IL-6 receptor, according to Femta Chief Scientific Officer Peter Emtage. Consequently, it takes much less antibody to block IL-6 than it does to block the receptor, he said.

This means Femta’s Fm101 could be administered through subcutaneous injection, which would enable patients to dose themselves at home, he said. Femta expects the drug to enter the clinic in the first half of 2011.

San Diego-based Femta has access to a protein-engineering technology used to select and optimize desirable features into a given antibody. In addition to IL-6, it’s also working on antibodies to targets such as IL-23 that are involved with various inflammatory conditions. As virtual company, it has no plans to bring these drugs to market itself. Instead, it will look to license them.

PolyTherics Ltd., of London, aims to offer advantages over today’s biologics through a pegylation technology that is says enables it to site-specifically pegylate any protein or peptide. Pegylation, the addition of polyethylene glycol, improves a drug’s duration of action.

The company aims to use this technology to develop bio-better versions of treatments such as interferon alpha and interferon beta. Its lead product is designed to be an improved version of interferon alpha-2a, a treatment for hepatitis. [This seems like a questionable business proposition for reasons that should be obvious to readers of this board.]

The company’s version, which looks to have better activity than existing drugs, may offer multiple advantages, including the potential for better dosing convenience, according to CEO Keith Powell. PolyTherics investors include Imperial Innovations Group, Capital Fund and Longbow Capital.‹

[DewDiligence]

FDA guidelines for FoB’s are near, Hamburg says:

http://www.bloomberg.com/news/2011-02-18/fda-says-rules-for-copying-amgen-biotechnology-drugs-to-arrive-very-soon-.html

“This is critically important,” Hamburg said today in an interview. “We obviously have been thinking about this for some time as different models have been discussed and debated. We will be more formally implementing in the very near term time frame.”

The comment was made at the GPhA meeting going on now.

[DewDiligence]

Obama administration now favors 12 years of worldwide marketing exclusivity for new biologics (consistent with US policy):

http://www.pharmalive.com/white-house-pushes-12-year-exclusivity-for-biologics-in-trade-talks

This is a change; previously the Obama administration had lobbied Congress to shorten the 12-year period afforded by the AHA.

[DewDiligence]

FDA’s May 2014 draft guidance on FoB’s (18 pages):

http://t.co/bnqAgAQaqb

Additional color from FierceBiotech:
http://www.fiercebiotech.com/story/fda-breaks-silence-biosimilars-long-awaited-proposal/2014-05-14#ixzz31i4bPyry

[DewDiligence]

FDA accepts for review NVS’ 351(k) Neupogen-FoB submission:

http://www.novartis.com/newsroom/media-releases/en/2014/1835571.shtml

This is the first 351(k) submission ever accepted by the FDA.

351(k) is the designation for the FoB-approval pathway established in 2010 as part of the ObamaCare legislation (#msg-48581353).

NVS’ Neupogen FoB is already marketed in more than 40 countries under the brand name, Zarzio.

[DewDiligence]

US FoB activity to date:

http://www.biocentury.com/dailynews/politics/2015-09-17/four-biosimilar-blas-in-limbo

Director Janet Woodcock of FDA's Center for Drug Evaluation and Research (CDER) shed new light on the biosimilars development pipeline during her congressional testimony on Thursday [yesterday]…

Woodcock told the Senate Health, Education, Labor and Pensions committee that as of July 31, 57 proposed biosimilars to 16 different reference products were enrolled in FDA's Biosimilar Product Development (BPD) Program.

Her written testimony added that "sponsors of an additional 27 proposed biosimilar products have had a Biosimilar Initial Advisory meeting with FDA, but have not joined the BPD program to pursue the development of these products."

One FoB product—Zarxio from NVS—has been approved by the FDA to date.