The Top 5 Upcoming Biosimilar Approvals in the U.S.

According to Biosimilarpipeline, more than 660 companies worldwide have about 700 biosimilars in development.  A biosimilar is, loosely, a generic version of a biologics drug. But unlike a generic drug, which is an exact copycat of a branded drug, a biosimilar is “similar,” to a branded biologic, but not a direct copycat. As a result, biosimilars require clinical trials and more regulatory approvals before hitting the market.

As Managed Care Magazine notes, however, “The core market boils down to a much shorter list of biosimilars of blockbuster biologics with patents that have expired or will do so in in the next few years. Biosimilar makers don’t need to wait till patents have expired to get FDA approval, and patents can be added or cleverly extended, but the commercial and legal outlook for a biosimilar improves if a key patent is ending.”

According to the U.S. Food and Drug Administration (FDA), only nine biosimilars have been approved by the agency in the U.S. Europe has a higher number of biosimilars approved. In the U.S., they include Sandoz’s Zarxio, a biosimilar for Amgen’s Neupogen; Pfizer’s Inflectra for Johnson & Johnson’s Remicade; Sandoz’s Erelzi for Amgen’s Enbrel; Amgen’s Amjevita for AbbVie’s Humira; Merck’s Renflexis for J&J’s Remicade; Boehringer Ingelheim’s Cyltezo for AbbVie’s Humira; Amgen and Allergan’s Mvasi for Genentech’s Avastin; Biocon and Mylan’s Ogivri for Genentech’s Herceptin; and Pfizer’s Ixifi for J&J’s Remicade.

Here are five biosimilars with upcoming PDUFA dates.

#1. Pfizer’s biosimilar to Herceptin. PF-05280014 has a PDUFA date of May 10. On September 10, 2017, Pfizer submitted the marketing applications to the FDA and the European Medicines Agency (EMA) for this biosimilar to Herceptin for the treatment of HER2-positive breast cancer and gastric cancer.

#2. Addelo Biologics’ biosimilar to Neupogen. This filgrastim biosimilar has a PDUFA date of May 11. The FDA accepted Addelo’s biosimilar application on September 11, 2017 for Neupogen to treat low white blood cells caused by a number of conditions, including neutrophenia in cancer patients receiving myelosuppressive chemotherapy.

#3. Sandoz’s biosimilar, ABP 980, to Herceptin. This rituximab biosimilar has a PDUFA date of May 12. In related news, on May 3, the FDA issued a complete response letter (CRL) to Sandoz’s submission for a biosimilar to Roche’s Rituxan. Little background information was given, but Sandoz issued a statement saying that it “stands behind the robust body of evidence included in the regulatory submission.” It plans to evaluate the contents of the letter and will work with the FDA on resolving any issues. The biosimilar for Herceptin was given a positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) in Europe in mid-March of this year. If approved by the European Commission (EC), it will become the third biosimilar version of Roche’s Herceptin available in Europe.

#4. Celltrion and Teva Pharmaceuticals' Herzuma biosimilar to Herceptin. This has a PDUFA date of May 30. Herzuma received approval by the EC in February 2018 and was approved in all 28 EU member states, Norway, Lichtenstein and Iceland. It had received approval from the Korean Ministry of Food and Drug Safety (MFDS) in January 2014. The U.S. FDA accepted it for review in July 2017.

#5. Amgen and Allergan’s ABP 980 biosimilar to Herceptin. This has a PDUFA date of May 31. The CHMP of the EMA recommended this biosimilar on march 23, 2018. “The positive opinion issued by the CHMP for ABP 980 marks an important step for our biosimilar portfolio, as it’s our second oncology biosimilar to reach this important milestone, and further underscores our commitment to providing the oncology community access to high-quality cancer therapies,” said Sean Harper, Amgen’s executive vice president of Research and Development in a statement. “We look forward to continuing our work with Allergan and European regulatory authorities to bring additional options to patients with cancer.”

Many companies rigorously defend their patents from biosimilar competition, but the reason for so much emphasis on it is clear. Managed Care Magazine writes, “The amount of money at stake is impressive. The IMS Institute report, which was funded by Novartis, projects that without biosimilar competition, a total of $225 billion will be spent on eight top-selling biologics in the United States and five European countries (Germany, France, Italy, Spain, and the United Kingdom) between 2016 and 2020. But those eight biologics are losing patent protection, and IMS calculates that the cumulative savings from biosimilar competition from 2015 to 2020 could range from $45 billion (if the discounts are 20 percent) to $90 billion (if they are 40 percent).”