Views on the exclusivity period of biogenerics

Bio and GPhA have released statements about the twelve year exclusivity period that was amended by the Senate Committee on Health, Education, Labor, and Pensions (HELP) for biologics last week.

Bio stated “the HELP Committee has embraced our long held belief that a minimum of 12 years of data exclusivity establishes a fair and reasonable period to ensure continued biomedical innovation and provide the benefits of expanded competition.”

GPhA President and CEO Kathleen Jaeger claimed that her company would “continue to fight in the House to ensure a true balance is achieved between innovation and competition.”

For a more in-depth look at the reactions, read here.

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Exclusivity period for biologics

Obama believes that biologics should be able to face competition after seven years on the market instead of 12-14.

Nancy-Ann DeParle, director of the Office of Health Reform, and Peter Orszag, director of the Office of Management and Budget wrote a letter to Rep. Henry Waxman stating

"Lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs."

Read the full article here.

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Biogen Idec lobbying for approval process for biosimilars

According to Forbes, Biogen Idec has spent over $290,000 lobbying for an approval process from the federal government for biogenerics. There is currently only an approval process to approve generic versions of chemical based drugs.

According to the article: The generic drug industry has put its support behind bills calling for about five years of market exclusivity for biotech drugs before competition can be introduced in the market. The biotech industry has been supporting proposals for up to 14 years of competition-free sales. Both sides are at odds over how much time it takes for companies to recoup development costs and make a profit.

Read the full article here.

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Biogenerics Are on the Rise

India, although a leader in producing a big portion of the world's generic requirements, has recently been facing difficulties because of their counterfeit drug shipments in the EU. Now according to this article in Patent Baristas the introduction of the Bipartisan Biogenerics Consensus Bill in the US will open up the US market to biogenerics. This means good news!

The bill is intedned for the FDA to approve generic biotech drugs and also provide a regulatory setup. The US has recognized the need for more affordable drugs as many patients are not able to purchase brand name drugs. The GPhA, Global Pharmaceutical Association, mentions this on their website:

“As our nation acts to strengthen our health care system, our priority must be to reduce costs while increasing access to quality care.”

It will be interesting to see the biogeneric market grow within the next couple of years.

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