By Ed Lamb, DrugPatentWatch writer
Under a new commissioner dedicated to bolstering competition to reduce prices, the agency is redoing a raft of rules and guidances to speed ANDA approvals and biologic licensing.
FDA spent 2017 approving record numbers of generic medications and biosimilars. The agency’s goal, reaffirmed for 2018, was to drive down drug prices by making more drug products available.
The jury remains out whether the strategy will improve patients’ and payers’ bottom lines. What is clear is that the opportunities for generic drugmakers to get their ANDAs approved and biologics licensed have rarely looked better.
Companies that specialize in producing high-volume/low-cost medications appear to have the most to gain from FDA’s commitment to introducing competitors to single-source medications. At the other end of the market, firms willing to invest in creating equivalents to blockbuster biopharmaceuticals can expect to encounter fewer hurdles while going through the BLA review process.
Table of Contents
FDA Rolls Out a Plan to Foster Competition
After enactment of the Generic Drug User Fees Amendments of 2012, it looked uncertain whether having drugmakers pay more of the costs for reviewing ANDAs would result in faster decisions and more approvals. While 440 unbranded medications were approved for the U.S. market during 2013, that number declined to 409 in 2014.
The pace of ANDA approvals picked up in 2015, raising to 495 products. A record of 651 generics received FDA approval in 2016. That total was greatly surpassed in 2017, when the agency OK’ed 763 generics.
Reauthorization of the GDUFA and the step-by-step rollout of a Drug Competition Action Plan deserve some of the credit for this boom in new generics.
FDA Commissioner Scott Gottlieb made developing and implementing the plan a top priority upon taking office in May 2017. He released the first details a little more than a month into his term, highlighting new rules intended to reduce brand name drug manufacturers’ ability to limit access to dosages for analysis by stretching the intent of risk management plans or by entering into restrictive contracts with wholesalers.
The second part of the plan, which became public in October 2017, aims to increase generic competition among injectable, inhalational and combination medications. FDA calls these products complex drugs and believes that companies hesitate to “genericize” them because demonstrating therapeutic and bioavailability equivalence can be time-consuming and expensive under current ANDA rules.
The agency in particular wants to redesign the presubmission meeting process to reduce the need for lengthy back-and-forth over packaging issues and chemical test results. FDA also called attention to the need for more generic drugs based on peptides, which include glucagon, liraglutide, nesiritide, teriparatide and teduglutide.
Seeking Three or More Products for Each Drug
Gottlieb set approving at least three products for each off-patent medication as a long-term goal. This articulates a central idea behind a March 2016 Center for Drug Evaluation and Research Manual of Policies and Procedures titled Prioritization of the Review of Original ANDAs, Amendments, and Supplements.
With so many older medications now available from only one manufacturer, or going off the U.S. market completely, the MAPP promises that FDA will move new ANDAs for sole-source drugs to the front of the review queue. While the agency does not intend to make many suggestions to companies regarding which specific medications to target for competition, it does maintain this regularly updated list of drugs that are in short supply — often due to problems at the plant of a single manufacturer.
Biosimilars Poised for Breakout
As the accompanying table of medications coming off patent in the United States by the end of 2022 shows, biotech drugs will become increasingly open to competition. Provisions of the Affordable Care Act made such possibilities realities, and FDA licensed five biosimilars in 2017.
The new products joined just four others licensed since 2015. According to the Biologics Blog, FDA currently has at least six other biosimilar BLAs under review.
Speaking at the Washington Post Chasing Cancer Summit in September 2017, Gottlieb forecast a slow ramping up of biosimilar licensing and noted that the agency then had 27 biotech companies requesting information on preparing BLAs.
He added, “I think we’re going to see a real pickup in the rate of biosimilar development. I think we’re at the early stages of biosimilar, similar to where we were 30 years ago with generic drugs.”
To spur the submission of biosimilar BLAs, FDA issued new guidance on using statistical methods to demonstrate similarity with innovator biologics. The agency also pledged in its 2018 Strategic Policy Roadmap to issue a Biosimilar Innovation Plan and to “create better incentives for the adoption of safe, effective and high-quality biosimilar drugs.”
