Generics Squawk At Biotech Copycat Bill

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stinky.jpgNo, generic drugmakers aren’t thrilled. The Senate health committee voted unanimously in favor of a bill that authorizes the FDA to approve biosimilars, or generic versions of biotech drugs. The legislation, which was jointly sponsored by Democrats and Republicans, includes some stiff compromises for generic companies.

The bill requires generic drugmakers to provide the FDA analytical data and at least one clinical trial showing their generic is as safe and effective as the original med. The FDA could waive that requirement in certain cases. But generic drugmakers couldn’t apply until a biotech med they want to copy has been on the market for 12 years.

“Such an arbitrary and excessive period of time is not only unprecedented and unwarranted, but more importantly, would unjustifiably delay access to affordable competition and choice for consumers and businesses alike,” says Kathleen Jaeger, ceo of the Generic Pharmaceutical Association.

“Second, we believe another flawed provision would permit brand companies to make a minor change to their product and receive an additional 12 years of exclusivity. This provision could allow brand companies to make multiple minor changes to their products and receive 12 years for each change, in effect maintaining their monopolies in perpetuity. This practice, commonly known as ‘evergreening,’ would essentially prevent safe and affordable life saving biogenerics from ever reaching patients.”

The legislation approved by the Senate committee would also give FDA authority to approve generics as “interchangeable” if there’s evidence that the new version will produce the same clinical results and not pose risks to patients who switch between the generic and brand-name products, Bloomberg News notes.

Drugs that aren’t approved as interchangeable would be called biosimilar, terminology already used by European regulators. Generic drugmakers complain such labeling would require spending a lot on marketing to persuade docs and patients to use biosimilars.

Despite the complaints, generic drugmakers are expected to acquiesce if legislation allows them to proceed. “It is in the generic companies’ interest to get legislation as quickly as possible,” Dan Mendelson, president of Avalere Health LLC, a Washington research group, tells Bloomberg. “I think they have come to accept the idea that anything they will do will have to require clinical testing and they have to get on with it.”

Late in the day, the BIO trade group, not surprisingly, praised the bill, but biotechs didn’t get everything they want either. They listed such items as more intellectual property protections and 14 years of data exclusivity. You can read the statement here.

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