FDA to review first biosimilar application

Could the regulatory and scientific logjam that’s keeping copycat biotech medicines off the market and out of the hands of patients and health providers in the United States finally be breaking?

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The Food and Drug Administration defines biosimilars as products that mimic their original, already-approved biologically engineered counterpart, “notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biosimilar and the approved biological product in terms of the safety, purity and potency.”



Thus far, that distinction has been academic within the U.S. pharmaceutical market, which has yet to see its first biosimilar approved for marketing by the FDA despite their common use in many other countries. But some four-and-a-half years after Congress and the White House enacted legislation calling on the agency to establish a review and approval pathway for biosimilars — and five years after passage of the Biologics Price Competition and Innovation Act of 2009 laying the groundwork for that approval process — there are signs that such a pathway is finally beginning to emerge.



In July, Novartis’ Sandoz unit became the first company to file for approval of a biologically engineered me-too pharmaceutical under the bio-similars pathway created by Congress and the Obama administration.



Sandoz announced that the FDA had accepted its biologics license application for filgrastim, a biosimilar modeled after Amgen’s Neupogen for the treatment of infection in patients receiving myelosup-pressive anticancer drugs. “The FDA’s acceptance of Sandoz’s filing is an important first step in increasing U.S. patient access to affordable, high-quality biologics,” the company noted in a statement.



Sandoz already markets filgrastim under the brand name ZARZIO in more than 40 countries outside the United States, according to the company. If approved by the FDA, the drug would be the first biosimilar available in the United States as early as 2015.



Meanwhile, investigational new drug applications for biosimilars continue to trickle into the FDA, with the agency receiving a total of eight INDs as of the end of June.



The Patient Protection and Affordable Care Act envisions what the FDA calls “an abbreviated licensure pathway for biological products that are demonstrated to be ‘biosimilar’ to or ‘interchangeable’ with an FDA-licensed biological product. But clearing that pathway for complex, biologically derived large-molecule compounds has been slow going. The agency, said FDA commissioner Dr. Margaret Hamburg, has labored to develop a review and approval process that sets “high standards for approval.”



“Building a new approval program of this complexity takes much time and deliberation, and that’s certainly been the case,” Hamburg said. “Congress deliberately set a very high bar for a biosimilar product approval. Manufacturers must demonstrate that their product is highly similar to, and differs in no clinically meaningful way, from the previously licensed product, known as the reference product, in terms of safety, purity and potency.”



Despite the slow, careful pace of progress at the FDA, the generic industry group predicts “a bright outlook for biosimilars,” with biologics amassing a total of some $60 billion in combined annual global revenues either already off patent or facing loss of patent protection over the next two years.