Biosimilars: Is it ever too early for safety?

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  • 10/15/2013

An excellent article from BioWorld on the continuing saga on biosimilars from Sacramento to Singapore.

Some snippets …

The U.S. Battle of Biosimilars Continues on Multiple Fronts

By Mari Serebrov, Washington Editor

While the first biosimilars to hit the U.S. are still in development, the battle over how and when the follow-on biologics should be marketed continues to rage on both the local and global fronts.

A skirmish in California ended Saturday when Gov. Jerry Brown vetoed a bill, overwhelmingly passed by state lawmakers, that would limit automatic biosimilar substitution to those the FDA deems “interchangeable.” SB 598 also would have required pharmacists to notify physicians when an interchangeable is substituted for a prescribed biologic.

“Obviously, the governor gave himself a little wiggle room here,” Peter Pitts, president of the Center for Medicine in the Public Interest, told BioWorld Today.

Pitts disagreed with the governor about the timing of the bill. “It’s never too early to say we need to educate doctors and patients about what’s going on,” he said, stressing the importance of promoting safety and pharmacovigilance in the use of biosimilars.

“The untrained ear hears ‘identical’” when biosimilars are mentioned, Pitts said, but the follow-ons are not the same as generic drugs. Noting that even generics, which are supposed to be identical to the reference drug, can have variants that could affect an individual patient’s response, he pointed out that due to their complexity, biosimilars could produce more variances.

Global Battle

While the substitution battle continues on the state level, another biosimilar war is raging on the global front as the countries negotiating the Trans-Pacific Partnership (TPP) push to finalize the trade talks this year. Despite efforts to have the agreement reflect the 12 years of data protection that biologic innovators enjoy in the U.S., the issue hasn’t made it to the 3-year-old negotiating table yet.

Opposition to including the data protection in the TPP is framed, once again, as an issue of increased access. But it really comes down to some of the partners wanting to maximize their own opportunities, Pitts said.

He noted that the 100 most essential drugs identified by the World Health Organization are all off patent, which means they’re available as generics. But people in many countries still don’t have access to those essential small-molecule drugs, so Pitts questioned the assumption that reducing or removing biologic data exclusivity would increase global access to biosimilars, which are more complex and costly than generics.

The complete article can be found here.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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