Sector News

Bad news for biosim makers: FDA sets 'high bar' in interchangeability guidance

January 18, 2017
Life sciences

The FDA rolled out much-awaited biosimilar interchangeability draft guidelines Tuesday, tipping its hand to developers looking to challenge sales of the world’s top biologics.

The gist? Winning the designation won’t be easy, but a big payoff could await for those who do.

Together, the guidelines (PDF) outline requirements for biosimilar developers looking to prove that their versions are interchangeable with the original brands. If deemed so, branded scripts could be filled with biosims instead without the prescribing doctor’s approval, similar to generic versions of traditional meds.

But the requirements for that designation, according to analysts, appear to be more stringent than biosim makers would like. The current draft would require switching studies more complicated than many now in the works, for instance.

Barclays analysts wrote Tuesday that the draft guidelines set a “high bar” to win interchangeability, “most notably requiring switching studies include two exposure periods for each product.”

Biosim developers can take comfort knowing that interchangeability isn’t required for an approval, the analysts pointed out, as knockoff versions now on the market attest, including Novartis’ first-to-market biosim Zarxio. Nor will interchangeability “be necessary for commercial adoption,” they said; indeed, pharmacy benefits managers’ 2017 formularies have excluded some originator brands in favor of recently approved biosims.

“However, the draft guidance suggests we might be waiting longer before seeing an interchangeable biosimilar come to market,” Barclays pointed out.

Despite the details in the document, however, Bernstein analyst Ronny Gal wrote that the “main value of the guidelines is in their actual release” as companies working on biosims can now seek interchangeability. Novartis, for one, has stated interchangeability as a primary goal of its biosim efforts, Gal wrote.

Notably, based on information publicly available, no Humira biosim developers have study designs that would meet the interchangeability requirements of the draft guidelines, according to Barclays. Amgen has an approved Humira biosimilar in Amjevita, while Novartis, the Merck Group and Momenta are working on their own versions.

“Some of this may be due to the fact that sponsors are not required to fully disclose [trial] designs, and we expect developers have been receiving informal guidance from FDA during regular development-stage meetings,” the analysts wrote in a note Tuesday.

Gal figures the guidelines “will make it hard for non-interchangeable biosimilars to sell when an interchangeable one is available.” He pointed out that first-entrant biosims could be “supplanted” as companies with follow-up products shoot for the designation.

The FDA is seeking comment on the draft for 60 days before forming its final interchangeability rules. The guidelines come at a key time for the industry, as many of the world’s top drugs face biosim threats in the coming years.

By Eric Sagonowsky

Source: Fierce Pharma

comments closed

Related News

January 29, 2023

Colorcon, Inc. signs Put agreement with intent to acquire controlled atmosphere packaging specialist Airnov Healthcare Packaging

Life sciences

Airnov provides critical healthcare industries with high-quality, controlled atmosphere packaging, to protect their products from moisture and oxygen. The business has manufacturing facilities in the USA, France, China and India and employs around 700 people.

January 29, 2023

Takeda pledges up to $1.13B for rights to Hutchmed’s cancer drug fruquintinib outside of China

Life sciences

Takeda of Japan has partnered with Hong Kong-based Hutchmed, gaining the commercial rights to colorectal cancer drug fruquintinib outside of China for $400 million up front, plus $730 million in potential milestone payments. Takeda also will help develop fruquintinib, which can be applied to subtypes of refractory metastatic colorectal cancer, regardless of biomarker status, the companies said.

January 29, 2023

Vir taps Bayer dealmaker Marianne De Backer as its next CEO

Life sciences

On April 3, Scangos, who’s been chief executive officer at Vir since the start of 2017, will hand over the reins to Marianne De Backer, Ph.D. De Backer comes over from Bayer, where she currently heads up pharmaceutical strategy, business development and licensing. Alongside her CEO appointment, De Backer is set to join Vir’s board of directors, the company said Wednesday.

How can we help you?

We're easy to reach