FTC workshop: Questions remain on biosimilar troubles in the US

Although the US FDA has yet to approve any biosimilars, unlike their European counterparts, bills have already been enacted in Oregon, Utah and Virginia requiring pharmacists to inform prescribers if biosimilars are substituted for biologics.

Sumant Ramachandra, SVP and chief scientific officer of Hospira, cautioned that there are still a lot of unknowns on biosimilars. “We have to be led by science and data. The health authorities are the adjudicators​.”

Despite these sentiments, the EU has approved biosimilars and taken a lead​ that the US FDA has seemed reluctant to follow.

Geoffrey Eich, executive director of R&D policy at Amgen, added: "Biologics cannot be like generic drugs…Empirical data demonstrate the need for complete and accurate medical records from patients​."

Still, some think the US FDA’s decision to wait on the EU to take the lead on biosimilars is a good idea. "FDA-approved biosimilars will be the most deeply analyzed and predictable products to hit the market​," consultant Emily Shacter, PhD, said.

Bruce Leicher, SVP of Momenta, added, “There has been a long established campaign against biosimilars for over 10 years…efforts are now underway that seek to restrict access​” to biosimilars.

"The opposition failed at the federal level and now seeks to use the same anti-competitive messages to enact laws to deter investment​,” he added as a warning.

The US​ FDA is the only US regulatory body with the scientific expertise to determine interchangeability, Jessica Mazer, JD, assistant vice president of state affairs at the Pharmaceutical Care Management Association (PCMA), said. The PCMA also called the recently enacted state legislation "onerous​" and "premature​."

"Small differences between biosimilars and reference products are unavoidable and will be detected​," Shacter said, commending the FDA on their patience.

But some think there will need to be more than just approvals for physicians in the US to be comfortable in prescribing biosimilars.

Ronny Gal, senior research analyst at Bernstein Research, added, "The adoption of biosimilars is critically dependent on market infrastructure​.”