The Burrill Report


Drugmakers seeking to market biosimilar versions of approved biotech drugs in the United States got long-awaited guidance from the U.S. Food and Drug Administration this week, clearing the path for the introduction of tougher competition, and potentially better patient access and lower prices for consumers.

While the rules of the road for seeking approval for novel biologics in the United States are fairly well known by drugmakers, the draft documents provide a map for companies seeking to navigate their way to participation in what IMS Health estimates will, by 2015, become a global $1.9 to 2.6 billion market for copies of the biotech drugs.

Biosimilars are highly similar to already-approved biologics, notwithstanding minor differences in clinically inactive components. In the United States, only a handful of such drugs have been approved so far. But with biologics accounting for $138 billion in sales during 2010 sales, according to IMS, payers are eager to see biosimilars, which stand to chop 20 percent to 40 percent from the price of innovator biologics, approved.

“We are pleased that the FDA has developed these important guidances, marking another important step forward on the pathway to biosimilars,” says Jim Greenwood, president and CEO of the Biotechnology Industry Organization. “We look forward to reviewing the drafts in detail to ensure that they comply with our key principles, particularly ensuring patient safety, recognizing scientific differences between drugs and biologics, maintaining the physician-patient relationship and preserving incentives for innovation.”

The new guidance outlines the process by which the FDA will approve biologics based on the demonstration that they are biosimilar to, or interchangeable with reference products, biologics already approved by the FDA.

The documents are also intended to communicate the agency’s current thinking on the key scientific and regulatory factors involved in submitting applications for biosimilar products for review.

“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,” says Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research.

Introduction of the new guidance for biosimilars comes close on the heels of another agency effort, the creation of a biosimilars fee program. That program, the Biosimilar and Interchangeable Products User Fee, would charge fees to applicants to the agency for products in development to generate revenue to provide it with the resources needed to support development-phase meetings with sponsors of biosimilar candidates.

With both the biosimilars guidance documents and the user fee program submitted to Congress for review and approval, industry advocates are eager to move ahead. The big work—surmounting the high costs of entering the biosimilars market, navigating intellectual property disputes, and convincing doctors and patients that generic biotech drugs are just as safe as innovator therapeutics—remains ahead.


February 10, 2012
http://www.burrillreport.com/article-fda_unveils_biosimilars_guidance.html