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FDA approves first biosimilar product

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WASHINGTON — Zarxio (filgrastim), a cancer treatment from Sandoz Inc., has become the first biosimilar product approved in the United States.

The Food and Drug Administration announced its approval of Zarxio, a biosimilar to Neupogen, an oncology product from Amgen Inc., on Friday. The move is being hailed as a watershed event that paves the way for future biosimilars and the potential to reap significant savings for the health care system.

“The FDA approval of Zarxio marks a significant milestone for the United States health care system and for patients who might suffer from neutropenia,” Carol Lynch, global head of biopharmaceuticals and oncology injectables at Sandoz, said in a statement. “As the global leader in biosimilars, we are honored to be the first company to successfully work with FDA to navigate the U.S. biosimilar pathway, and we look forward to making this high-quality biosimilar available to patients in the U.S.”

FDA Commissioner Margaret Hamburg noted that, to be approved, a biosimilar must demonstrate that it has no clinically meaningful difference in terms of safety and effectiveness from the reference product. Zarxio was approved for the same indications as Neupogen.

“Biosimilars will provide access to important therapies for patients who need them,” Hamburg stated. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality ­standards.”

The approval heralds a new era for cancer patients and American health care, “one where access to safe, affordable versions of lifesaving biologics will finally be a reality,” according to Ralph Neas, president and chief executive officer of the Generic Pharmaceutical Association (GPhA).

“Consumers, employers, private insurers, taxpayers, state governments and federal programs all will benefit from the advent of biosimilars, as intended by the Biologics Price Competition and Innovation Act that was enacted as part of the Affordable Care Act,” Neas commented.

The Biologics Price Competition and Innovation Act created an abbreviated licensing pathway for biologics shown to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product (i.e. the reference product). The FDA noted that the abbreviated pathway allows reliance on certain scientific knowledge about the safety and effectiveness of the reference product and permits a biosimilar biological product to be licensed based on less than a full complement of product-specific preclinical and clinical data.

Prime Therapeutics LLC, a pharmacy benefits manager (PBM), called for more legislative and regulatory clarity on ­biosimilars.

“A robust market for biosimilars may be in jeopardy if regulators and lawmakers on federal and state levels adopt adverse regulations that create steep hurdles for biosimilar manufacturers,” stated Peter Wickersham, a senior vice president at Prime Therapeutics.

Edith Rosato, CEO of the Academy of Managed Care Pharmacy (AMCP), called the approval of the first U.S. biosimilar “an important step in increasing access to life-saving and life-improving biologics” but noted that the move was just a first step for broader use of biosimilars.

“Much work needs to be done to promote their use and acceptance,” Rosato explained. “The FDA should next end the heated debate over biosimilars naming and require that biosimilars and their branded biologic counterparts share the same nonproprietary name. The FDA should also issue clear rules for designating a biosimilar product as interchangeable with a reference product.”

AMCP said that in a recent poll of pharmacists published in the Journal of Managed Care & Specialty Pharmacy (March 2015), about three-quarters of respondents said they would feel confident or very confident substituting an interchangeable biosimilar for its branded biologic counterpart if the two products share the same nonproprietary name.

Only about 25% of pharmacists would feel as confident if the products had different nonproprietary names, according to the survey, conducted by consulting firm Xcenda, an AmerisourceBergen company.


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