As Biosimilar FDA Approval Nears, What Can Be Learned from India?

January 13, 2015

by Amanda Conschafter, blog editor

Last week, the United States inched closer to its first biosimilar approval. At a Wednesday meeting of the Food and Drug Administration’s Oncological Drugs Advisory Committee, panelists recommended approval for a filgrastim biosimilar. The medication, which boosts white blood cell production for cancer patients, could offer a new therapy option at reduced prices.

But health care providers and patient advocates are concerned. As approval nears, FDA still fails to establish clear guidelines about naming conventions and the level of testing required for a biosimilar’s approved uses – vital issues for patient safety.

Robert Yapundich, MD, a member of AfPA’s National Physician Biologics Working Group, weighed in at the committee meeting, along with representatives from industry, patient organizations and academia. “As you…evaluate filgrastim,” Dr. Yapundich appealed to the panel, “I ask that you take this unique opportunity to forge a solid precedent for future biosimilars and make patient safety your top priority…” Dr. Yapundich requested that the panel “conside[r] the importance of distinct nonproprietary names, as well as a distinct biosimilar approval process for each indication.” Dr. Yapundich called anything short of these considerations “a strike against patient safety.”

Physician concerns are well founded. As countries across the world establish regulatory frameworks to accommodate biosimilar drug approvals, some protect patient safety better than others do. The European Union, for instance, has created and upheld standards that reflect the World Health Organization’s internationally acknowledged guidelines for drug safety. Other countries, particularly India, have been less disciplined in their regulatory approach.

Take India’s recent adalimumab biosimilar. Its creators claim “fingerprint-like similarity” to the brand-name product it resembles, and they offer the biosimilar at nearly one fifth the price. But available data casts doubt on this biosimilar’s safety and efficacy. Khrisna Sarma explains in the Hindustan Times that India’s clinical trials often entail only a tiny group of participants, 100-150 patients. Expanding the experiences of this group to the entire patient population could be risky.

Adalimumab’s developers are also drawing criticism over the drug’s approval timeline. Though biologics’ effect on patients’ immune systems typically requires six months to a year to monitor, adalimumab received approval based upon a mere 12 weeks of patient testing.

Concerns aren’t limited to adalimumab. As think tank scholar Roger Bate noted in a recent op-ed, “The country has a terrible track record when it comes to creating safe and effective pharmaceuticals.” Bate refers to recalls of hundreds of thousands of pills in India last year due to pill solubility and microbial contamination issues.

For patients, such blunders can prove dangerous. But beyond worrying U.S. regulators, India’s experience should spur them to action. Proceeding with biosimilar approval without first establishing approval guidelines that further patient safety is troublesome.

U.S. regulators would do well to take India’s experiences to heart. The country offers a powerful lesson: profit, speed to market and lower drug costs can all be good things – but not when pursued at the expense of patient safety.

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