[Ip-health] Biosimilar drugs

[Dolores Cullen]

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 PhRMA To Vote On Plan Requiring Distinct Common Names For Biosimilars

July 25, 2006

InsideHealthPolicy.com

The U.S. drug industry's trade group next month will vote on a plan that
would require biosimilars in Europe to be given different common names than
the brand-name biopharmaceuticals they copy. The proposal would make it
impossible for biosimilars to be substituted for branded drugs. Generic
names are harmonized between the United States and the European Union so if
EU regulators adopt the policy, U.S. regulators may likely adopt it too --
if Congress allows biogenerics here.

Industry sources say the Pharmaceutical Research and Manufacturers of
America is slated to vote on the proposal from its European counterpart, the
European Federation of Pharmaceutical Industries and Associations (EFPIA),
and the European Biopharmaceutical Enterprises (EBE).

PhRMA declined comment. For a past article, a PhRMA representative said it
supports the general idea of giving different names to biosimilars, though
at the time no specific proposal existed (see FDA Week, April 25). The
Biotechnology Industry Organization also declined comment.

Industry touts the plan as one of a handful of potential drug safety
measures on biosimilars. Industry sources note that biosimilars are not
identical to the branded versions they reference, and say EFPIA wants to
ensure that adverse events caused by biosimilars are not attributed to
branded products.

But opponents of the proposal say it is a ploy to avoid generic substitution
and is not really aimed at drug safety. They argue that naming policies
should not be used to subvert FDA as the U.S. authority that determines if
pharmaceutical products are substitutable.

Under the proposal, the World Health Organization's International
Nonproprietary Names (INN) panel would give distinct names to biotechnology
products made by different manufacturers.

"This would be the legal name of the product in the EU, so that
prescriptions, pharmacy records, and other documents that are crucial to
effective pharmacovigilance would be more likely to reveal the actual
manufacturer of the product that each patient receives," a position paper
describing the proposal states.

The proposal would not completely ensure safety of biosimilars, the paper
states. For example, it says that post-market tests for antibodies, or even
registries or special studies, should be required for antibodies.

Another naming approach considered by EFPIA is to require that both branded
and biosimilar products bear brand names, the paper states. However,
Europeans would have to change their law to accomplish this, and the option
also would require changes in prescribing practices in the member states
because many physicians prescribe by common name.

Using existing post-market safety reporting also is an option, according to
the position paper, but, even with some changes, pharmacovigilance may not
distinguish between innovator biopharmaceuticals and biosimilars.

Another option would be "to classify biosimilars as 'non-substitutable' or
as subject to special 'restricted substitution' rules," the paper states.

However, this approach would require adopting a policy decision and changing
medical practice in every member state. In many member states physicians are
encouraged, or even obligated, to prescribe by common name. Even with a rule
prohibiting substitution, it could be difficult to link rare side effects if
multiple biosimilars bear the same common name.

FDA recently approved what many believe to be the first biogeneric in the
United States. Omnitrope is a generic of Pfizer's biologic drug Genotropin,
but it was approved under drug law, not biologics law. However, the generic
drug industry contends the approval shows that the science exists to make
safe and effective copies of biologics, opening the door for Congress to
handle the legal issues.--John Wilkerson



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