Biotech Strategy Blog

Commentary on Science, Innovation & New Products

Posts from the ‘Biosimilars’ category

Biosimilars could be a casualty of Supreme Court Health Care Decision

By on June 26, 2012

The decision expected this Thursday by the Supreme Court of the United States on the constitutionality of the Patient Protection and Affordable Care Act (PPACA) may impact the development and approval of biosimilars.

United States Capitol Building 300x225 Biosimilars could be a casualty of Supreme Court Health Care DecisionPart of the PPACA signed into law by President Obama on March 23, 2010 was the Biologics Price Competition & Innovation Act (BPCI).

This amended the Public Health Service Act (PHS) to create a pathway under section 351(k) for the licensing of biological products that are “interchangeable” or “biosimilar” to an FDA-licensed product.

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BIO 2011: my top 10 sessions at the BIO International convention in Washington DC

By on June 18, 2011

BIO 2011 International Convention Washington DC BIO 2011: my top 10 sessions at the BIO International convention in Washington DC

I am excited to be attending, for the first time, the Biotechnology Industry Organization (BIO) international convention that takes place in Washington DC in just over a week’s time from Monday June 27 to Thursday, June 30th.

This meeting has something for everyone interested in the biotechnology industry whether it be deal making, partnering, licensing, drug discovery or personalized medicine. There are 16 specialized tracks where industry experts provide insight and best practices.

In addition, there are numerous networking and social events plus an exhibit hall that showcases the world’s biotech regions and how they are promoting innovation.

This is a preview of BIO 2011: my top 10 sessions at the BIO International convention in Washington DC. Read the full post

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Amphastar sues FDA

By on October 27, 2010

The race to bring a biosimilar version of Sanofi-Aventis’ low molecular weight heparin, Lovenox® (enoxaparin sodium), to market had three players, Momenta Pharmaceuticals in partnership with Sandoz, Amphastar Pharmaceuticals and Teva.

The winner was Momenta/Sandoz who (as mentioned in a previous post) recorded $292 million of sales in 69 days post launch.   As reported by the Wall Street Journal, Amphastar are now suing the FDA alleging the agency acted arbitrarily in delaying its imports of raw heparin.  There certainly seems to be no love lost between Amphastar and the FDA, who earlier this year alleged a conflict of interest between Janet Woodcock, the Director for the Center for Drug Evaluation and Research (CDER) and Momenta as a result of the collaboration that identified the contaminant in chinese heparin that killed patients in 2008.  Following an FDA investigation, Woodcook was cleared of any conflict of interest but announced she would not participate in the biosimilar approval decision.

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FDA may seek tighter standards for approval of generics

By on October 25, 2010

The news, reported by Bloomberg, last week that generic companies may be subject to stricter FDA standards in order to show therapeutic equivalence is good news for the biotech industry and consumers.

Generic companies have a pretty easy ride in obtaining product approval, and I’ve long been convinced that the formulation of a brand, and what makes it work can include the so called inactive ingredients and how it is put together.   I know of many people who have experienced side effects with generics that they don’t have with the branded product.

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