Biosimilar Policy Roundup: October

The high cost of prescription drugs, the need for more competition in the marketplace, and the potential for biosimilars to provide substantial savings were key topics among biosimilars stakeholders in the month of October.

The Federal Trade Commission announced an upcoming workshop focusing on competition issues related to prescription drug marketing. The workshop, featuring a talk by FDA Commissioner Scott Gottlieb, MD, will address issues related to administration of both the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act.

In a Hatch-Waxman case before the Federal Circuit, a Texas judge called into question Irish drug maker Allergan’s recent transfer of patents for its dry-eye drug, Restasis, to the Saint Regis Mohawk Tribe. The Tribe invoked sovereign immunity against inter partes review of the patents in exchange for drug royalties. Judge William C. Bryson, who struck down the patents for the drug in a litigation unrelated to the transfer, asked whether Allergan’s gambit should be considered a “sham.” In a separate case, rival drug maker Shire filed suit against Allergan over Restasis, saying that Allergan tried to block Shire’s competitive drug from the Medicare Part D formulary.

The Senate’s Health, Education, Labor, and Pensions (HELP) committee heard testimony from industry on the high cost of prescription drugs; representatives of pharma groups, pharmacy benefit managers, and the supply chain faced pointed questions from Senators Lamar Alexander, R-Tennessee, and Patty Murray, D-Washington, among others, demanding to know the reasons for growing drug costs.

Lawmakers were not alone in raising the alarm on drug costs; newly published data in the Journal of Clinical Oncology shows that, despite competition, the cost of injectable anti-cancer drugs increases over time, with drugs such as rituximab and trastuzumab having increased in cost by 85.2% and 78.4%, respectively, over 12 years. (The World Health Organization announced that it will move forward with prequalification of biosimilars for both rituximab and trastuzumab, though it will not proceed with the use of biological qualifiers to assign international nonproprietary names to biosimilars). Other new data, included in a review published in PLOS One, found that changes in drug life-cycle dynamics, orphan drug programs, and unintended consequences of patent law can all lead to high-priced drugs.

Despite news of growing costs, a highly anticipated report by the RAND corporation estimated that the United States could save $54 billion on drug costs over the next 10 years by using biosimilars, but said that US policymakers will face the choice of allowing the market to continue to evolve under existing policy or intervening to help steer the market to a more competitive state.

Meanwhile, in the European Union, a new report prepared for Medicines for Europe by the Economist Intelligence Unit sought to identify the causes of medicines shortages, which are particularly likely to affect oncology drugs, among other products. The report pointed to economic factors (such as low demand, reference pricing, and parallel trade), supply-chain issues (including quality-related problems and inventory strategies designed to reduce waste), and regulatory delays as drivers of shortages. The authors proposed policy changes—including implementation of an EU-wide notification requirement for manufacturers to alert officials to potential shortages, improved tendering practices, and maintenance of a healthy multi-supplier marketplace—as ways to reduce the threat of future shortages.

The European Commission (EC) is taking steps toward patent reform, and is launching a public consultation on supplementary protection certificates (which add an additional 5 years to 20-year patent terms). Because these certificates are enforced at a national level, the Commission is considering legislative action to clarify their application. The EC is also preparing for its November vote on a new home for the European Medicines Agency (EMA), as nations continued to vie to become the new home for the regulatory body. The agency this month released its findings concerning the most suitable location, with Amsterdam and Barcelona earning top marks.

In the United Kingdom, currently the home of the EMA, trade group The Association of British Pharmaceutical Industry announced that the Administrative Court has denied its application for a review of a National Health Service (NHS) drug pricing policy. The NHS budget impact test applies to treatments that have been approved for routine NHS use but that will cost the system more than £20 million (approximately $26.3 million) in the first 3 years of use. Drugs that exceed the cost threshold will become subject to automatic price negotiations between the NHS and the drugmaker.