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Posts Tagged ‘FDA’

By Jeremy Grushcow

Use of social media by pharmaceutical companies, biotechs, and industry observers will continue to grow in scale, value and importance this year. The emergence of Twitter as a public health surveillance tool and the pending (still pending…) release of the FDA’s social media guidelines will contribute to this growth in the short term, and we’ll continue to keep an eye on novel developments.

This post is the first in a series briefly outlining the biotech industry trends we’ve been following on the blog and noting some recent developments, plus directions for 2011.

Re-posted from the Cross-Border Biotech Blog

Jeremy Grushcow is a Foreign Legal Consultant practising corporate law at Ogilvy Renault LLP. He has a Ph.D. in Molecular Genetics and Cell Biology. His practice focuses on life science and technology companies.

The RIC blog is designed as a showcase for entrepreneurs and innovation. Our guest bloggers pro vide a wealth of information based on their personal experiences. Visit RIC Centre for more information on how RIC can accelerate your ideas to market.

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By Jeremy Grushcow

Reuters reports that the European Medicines Agency (EMA), which has already approved 13 biosimilars, is expecting to publish guidelines in November on biosimilar antibody therapeutics. EMA Executive Director Thomas Lonngren said that clinical trials will be required for antibody biosimilars (as they are for the products EMA has approved to date), but that requirements were likely to be less onerous than in the United States.

Reuters says that the small number of requests (six) received by EMA so far “reflects the difficulties of making such copycat medicines [antibodies]” but with the earliest therapeutic antibodies coming off patent (in Europe) in 2014, I expect these initial inquiries are just the tip of the iceberg. Of couse, biosimilars are hard (as we’ve noted); but a lucrative opportunity of that scale will not go untapped.

Meanwhile, as expected based on the draft notice leaked in September, the FDA is holding public meetings on the implementation of the Biologics Price Competition and Innovation Act (i.e., the biosimilars legislation). The full Federal Register notice (pdf) is up, and Mark Sernak at eyeonfda.com has extracted the questions posted for comment.

In addition to a long list of scientific and technical questions, there are a couple of inquiries that I’d highlight from a corporate law perspective:

  1. Which types of related entities may be ineligible for a period of 12-year exclusivity for a subsequent BLA, given the “potential transfer of BLAs from one corporate entity to another and the complexities of corporate and business relationships”; and
  2. Whether the existing fee structure under the Prescription Drug User Fee Act (PDUFA) should be considered as a model in establishing a user fee structure for biosimilar applications.

Interested in attending or in submitting a comment? The FDA’s meeting information page is here, and it includes webcast access for November 2 and November 3.

Re-posted from the Cross-Border Biotech Blog

Jeremy Grushcow is a Foreign Legal Consultant practising corporate law at Ogilvy Renault LLP. He has a Ph.D. in Molecular Genetics and Cell Biology. His practice focuses on life science and technology companies.

The RIC blog is designed as a showcase for entrepreneurs and innovation. Our guest bloggers pro vide a wealth of information based on their personal experiences. Visit RIC Centre for more information on how RIC can accelerate your ideas to market.

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By Jeremy Grushcow

Adam Feuerstein at TheStreet.com reports on a draft FDA notice for a planned November meeting on implementation of the Biologics Price Competition and Innovation Act, which was passed as part of the healthcare reform legislation.

The BPCI Act (42 U.S.C. 262(k)(8)) provides for the FDA to author guidance “with respect to the licensure of a biological product” — pretty broad, so we’ll have to stay tuned for the actual meeting notice. However, the legislation provides some hint in permitting “product class-specific guidance” specifying criteria that will be used to determine whether a biological product is highly similar to a reference product in such product class.

If the FDA decides to move ahead with product class guidance, it would likely specify the criteria that will be used to determine whether a biological product meets the standards for “interchangeability”.

In other cases, the FDA may determine that “the science and experience [to date] … with respect to a product or product class … does not allow approval of a [biosimilar] for such product or product class.”

Bottom line: following the FDA’s November meetings, biosimilars will be one step closer in the U.S.

Re-posted from the Cross-Border Biotech Blog

Jeremy Grushcow is a Foreign Legal Consultant practising corporate law at Ogilvy Renault LLP. He has a Ph.D. in Molecular Genetics and Cell Biology. His practice focuses on life science and technology companies.

The RIC blog is designed as a showcase for entrepreneurs and innovation. Our guest bloggers pro vide a wealth of information based on their personal experiences. Visit RIC Centre for more information on how RIC can accelerate your ideas to market.

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Re-posted from the Cross-Border Biotech Blog

By Jeremy Grushcow

A provocative post by Matthew Herper at Forbes’ The Science Business Blog this week argues that special protocol assessments (SPAs) should be public.  SPAs are the FDA’s way of pre-approving a clinical trial design, so that a company can conduct its trials secure in the knowledge that the FDA won’t later withhold approval based on a design flaw.

SPAs are currently ”confidential communications” not subject to public disclosure, but Herper argues for congressional action to put them into the public record:

“It might take an act of Congress to allow the FDA to make SPAs public, but that should happen. This would increase their value to biotechnology firms who are trying to raise money and prevent run-of-the-mill stock buyers from getting fleeced.”

The event that triggered Herper’s call for new legislation is yesterday’s revelation that Seattle-based Cell Therapeutics deviated from an agreed protocol in 2008.  Herper characterizes this mainly as the FDA’s failure for leaving SPA disclosures “entirely up to the company” and says the confidentiality protection “represents one way in which the regulator fails to  make sure investors have information they need.”

However, as much as I’m a fan of government transparency, the responsibility to investors lies with the company not with the FDA.  To the extent details of an SPA are material, they should be disclosed.  Ongoing developments with respect to clinical trials should likewise be assessed as part of a company’s disclosure controls and procedures and disclosed as necessary.

Did Cell Therapeutics fail in this duty?  Unclear.  As an article by Adam Feuerstein pointed out on Feb. 1, Cell Therapeutics did disclose that they halted enrollment in the trial early.  However, the company did continue to reference the SPA in subsequent press releases.

Would FDA publication of the SPA have helped?  Also unclear.  The FDA’s guidance on SPAs (pdf) says, clearly:

“Failure of a sponsor to follow a protocol that was agreed upon with the Agency will be interpreted as the sponsor’s understanding that the protocol assessment is no longer binding on the review division.”

So I’m not sure what would have been added by having the SPA available.

My bottom line: Companies that fail to disclose material developments or that misrepresent material facts will subject themselves to liability to their shareholders.  Herper’s hope is that disclosure by the FDA would “prevent run-of-the-mill stock buyers from getting fleeced,” but absent evidence that securities laws are failing to provide adequate incentives or remedies, I’m not convinced that forcing these confidential FDA communications open to public scrutiny would help investors or patients.

Jeremy Grushcow  is a Foreign Legal Consultant practising corporate law at Ogilvy Renault LLP. He has a Ph.D. in Molecular Genetics and Cell Biology. His practice focuses on life science and technology companies.

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