FDA issues draft guidance documents for developing biosimilars

The FDA issued three draft guidance documents Thursday to assist pharmaceutical companies with the development of biosimilar products in the US. “When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process,” remarked Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research.

“These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers,” she added. According to Bernstein Research, biosimilars are expected to cost between 10 percent and 20 percent less than their branded equivalents, and could generate sales of $8 billion by 2020.

The documents provide the FDA’s current thinking on “key scientific and regulatory factors involved in submitting applications for biosimilar products.” The guidelines outline a series of steps that drugmakers must comply with to seek approval of a biosimilar medicine. Rachel Sherman, FDA associate director for medical policy, noted that it will be “an abbreviated pathway that will depend on existing data” on the branded product. “Instead of starting from scratch, these companies will be starting in the middle of the process,” Sherman said.

The new guidelines add details to the original proposal for introducing biosimilar drugs that was contained in President Barack Obama’s 2010 healthcare overhaul. The agency is seeking public comment on the documents before issuing final guidance.

According to Morgan Stanley Research, seven out of the top 20 selling drugs in the US in 2010 were biologics, led by erythropoietin, which had $3.3 billion in sales. Bernstein estimates that biologics with $30 billion in US sales are expected to lose patent protection by 2020.

However, Scott Foraker, head of Amgen’s biosimilars unit, cautioned that “there are so many unknowns commercially” for biosimilars. “We don’t know what the competitive environment will look like. We don’t know what the pricing will be. And there still is regulatory uncertainty,” he remarked. Meanwhile, Michael Kamarck, head of Merck & Co.’s biosimilar division, noted that the experience in Europe, where some biosimilar products are already approved, showed the need for “actively promoting” the medicines in order to get them used. “The essence is not going to be a typical generics business,” Kamarck added.