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Developments in Biosimilar Approvals, Litigation, Payment, and Policy


The past weeks have seen a number of important milestones for biosimilars, from product approvals and regulatory changes to policy updates and litigation developments.

FDA and European Medicines Agency (EMA) Approve New Biosimilars

Recent weeks have seen important regulatory developments for biosimilars; on August 25, the FDA approved Boehringer Ingelheim’s (BI) adalimumab biosimilar, Cyltezo, referenced on Humira. The product is the second adalimumab biosimilar to be approved, following Amgen’s Amjevita in 2016. On the same day, Samsung Bioepis announced that the EMA had approved its biosimilar adalimumab, Imraldi. The approval marks the company’s third anti-tumor necrosis factor (TNF) drug approval in the European Union. Another challenger to AbbVie’s blockbuster drug could be nearing; Coherus announced positive topline results for its adalimumab candidate just 3 days after the approvals of BI’s and Samsung Bioepis’ products.

Other biosimilar products have not fared so well with their anticipated regulatory action. Biocon’s trastuzumab biosimilar, which had been widely expected to receive approval from the FDA on its Biosimilar User Fee Act date of September 3, will not receive a decision from the agency until December. The drug maker also withdrew its filing for the drug from the EMA in August.

Biologics Price Competition and Innovation Act (BPCIA) Litigation Continues

Patent litigation continues between reference product sponsors and biosimilar developers, slowing product market entry in the United States. Amgen and Sandoz both filed supplemental briefs in an ongoing appeal related to the Supreme Court case of Sandoz v Amgen. In a separate BPCIA litigation, the US Court of Appeals for the Federal Circuit dismissed Amgen’s appeal of a previous ruling that had denied the company discovery of Hospira’s manufacturing processes for its epoetin alfa, biosimilar to Amgen’s Epogen. Sandoz’s biosimilar etanercept, Erelzi, which was approved by the FDA in 2016, continues to be the focus of patent litigation with reference product sponsor, Amgen. While the drug is not expected to be available in the United States until 2018, in August, the product launched in Canada.

Drug Makers Vie to Retain Market Share

Even as patent litigation drags on for US biosimilars, reference product makers who stand to lose sales of their biologics upon the arrival of biosimilar competition are developing innovative new products that may help them retain market dominance. Genentech, a member of the Roche group, has announced priority FDA review of its oncologic drug obinutuzumab, which the GALLIUM study found significantly improved progression-free survival over rituximab. Genentech also gained priority review of emicizumab, a hemophilia A prophylaxis treatment.

Payers and Governments Seek Cost Relief

As drug companies seek to hold on to their shares of lucrative treatments, payers are looking for ways to control costs. Reference pricing, a framework under which an insurer or employer establishes a maximum contribution that it will make toward the price of a drug or a procedure in a therapeutic class, has proven to be an effective way to reduce payer spending, but it also increases out-of-pocket costs for patients. Tapering and withdrawing anti-TNF treatments also resulted in lower costs to payers, but a recent study found that the approach is associated with worse disease control for patients with rheumatoid arthritis. State governments, too, have an interest in bringing down drug prices, and a number of states have passed or enacted legislation aimed specifically at curbing the growing cost of drugs.

Europe Pilots New Biosimilar Uptake Initiatives

Meanwhile, in Europe, nations eager to see greater cost savings in their health systems are piloting new initiatives to spur biosimilar uptake. In the Lazio region of Italy, local clinicians received specific guidance on using biosimilars, resulting in a 14.4% increase in the prescribing of biosimilar filgrastim for the prevention of febrile neutropenia. Ireland has launched a consultation on the nation’s approach to biosimilars, and the country’s National Cancer Control Programme has issued new guidance on the usage of biosimilars in the treatment of cancer.

Brexit Puts Pressure on the United Kingdom, EMA

UK stakeholders have hailed a new government position paper on Brexit that seeks to ensure the continued availability of drugs (and other goods) that are already in the single market. UK pharmaceutical companies are also calling for the government to make a £140 million (approximately $179.5 million) investment in pharmaceutical manufacturing to ensure a continued supply of drug therapies for the nation after its withdrawal from the European Union.

Meanwhile, the EMA is scaling back its activities to cope with its impending move from the United Kingdom to another, as-yet undetermined EU member state. The EMA and FDA hope that their limited resources can be put to more efficient use, however, with a new agreement that will allow the agencies to share confidential inspection information with one another.

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