New final FDA guidance begins to clear path for more biosimilars


As 2016 drew to a close, the Food and Drug Administration gave a gift of sorts to drug makers looking to submit to the agency an application for approval of a biosimilar drug when it issued its final guidance, “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.”

(To view the full Category Review, click here.)

The finalized guidance follows the draft guidance the agency issued in May 2014.

“Clinical pharmacology studies build upon the foundation of comparative analytical studies and normally are a critical part of demonstrating that there are no clinically meaningful differences between the proposed biosimilar product and the reference,” the guidance said. “These studies can be instrumental in addressing residual uncertainty in biosimilarity assessments, and also can inform the need for and design of any necessary subsequent clinical studies to address remaining uncertainties.”

The finalized guidance came a little more than three months after the FDA published its performance goals for fiscal years 2018 through 2022 under the Bioisimilar User Fee Act II, and it is one of five finalized guidances pertaining to biosimilars that the agency has published. And while the guidances that have been released have outlined important underpinnings of the path to approval, the industry is still waiting for the agency to resolve an important question with a forthcoming guidance, namely interchangeability.

QuintilesIMS predicts that in the next 10 years, biosimilars — whose prices are about 10% to 15% less than those of the original biologics — will generate healthcare spend savings ranging from $44 billion and $250 billion. As more approvals roll in for biosimilars — currently five biosimilars have been approved and three have launched — and some 50 biosimilars sit in the pipeline, one of the largest barriers that biosimilars face, besides patent litigation, is that of interchangeability.

“Until there’s clarity on what it takes to have that interchangeable status,… interchangeability will be a major determinant of a biosimilars’ potential and the ability for payers and providers to use these drugs as a source of competition,” Numerof & Associations research analyst Michael Kuchenreuther told Drug Store News.

In January, the FDA issued a draft guidance on interchangeability of biologic products that is accepting comments on it until March 18 for stakeholders who want their input to be considered before a final guidance is issued, which the agency has said it will issue by the end of 2017.

In the meantime, five biosimilars have been approved — Sandoz’s Zarxio (filgrastim-sndz), a biosimilar of Neupogen (filgrastim); Pfizer’s Inflectra (infliximabdyyb), a Remicade (infliximab) biosimilar; Basaglar, an insulin glargine biosimilar that challenges Sanofi’s Lantus; Erelzi (etancercept-szzs), an Enbrel (etancercept) biosimilar; and Amjevita (adalimumab), a biosimilar of Humira.

By 2021, QuintilesIMS projects that one to two additional insulin biosimilars will be approved, as well as one to two additional infliximab copies, seven to 10 biosimilars of adalimumab, one to two ranibizumab copies, one to four additional biosimilars of filgrastim, one to two of epoetin alfa, three to four of bevacizumab and two to three each of rituximab, trastuzumab and pefilgrastim.

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