Pfizer Signs Licensing Agreement With Roche on Trastuzumab Biosimilar

With Pfizer expecting to hear back on its 351(k) resubmission on a trastuzumab biosimilar in early 2019, Genentech and its parent, Roche, may have been getting nervous about their competitor’s intentions. After all, Pfizer was willing to launch at risk with its marketing of Inflectra®, the infliximab biosimilar manufactured by partner Celltrion. In fact, it is the only biosimilar manufacturer that has gambled on an at-risk biosimilar launch.

According to a report in the Pink Sheet, a district court filing on December 4 noted that the two parties signed a settlement that will put an end to their patent litigation, and presumably allow Pfizer to market its biosimilar trastuzumab in the US at a future date. As in previous agreements signed by Roche, the terms are confidential, and launch dates and licensing fees are unknown.

trastuzumab biosimilar

A similar confidential agreement was completed between Mylan and Roche, for Mylan and partner Biocon’s Ogivri®, the first trastuzumab biosimilar approved by the Food and Drug Administration (FDA) in April 2017.

Three other trastuzumab biosimilars are also trying to reach the market. Amgen and Allergan received a complete response letter in June 2018, and have not yet announced when it might resubmit its 351(k) application. Samsung Bioepis is awaiting its initial decision on its trastuzumab biosimilar, filed in January 2018. Teva and Celltrion seem to be on the cusp of an FDA decision, after receiving their initial rejection in July 2017.

Roche has it covered, though. It filed patient litigation against Samsung Bioepis in September 2018 and partners Celltrion and Teva as well.

This is the very situation that the federal government, payers, and patients want to try to avoid, however. Licensing fees paid to the reference manufacturers may work to significantly inflate the drug’s price to the health system. The lack of transparency characterizing these agreements and the associated delays in launch are being decried by those patients and entities who can benefit from access to biosimilar competition. Herceptin was first approved in 1998. No one envisioned Genentech having 20+ years of marketing exclusivity.

In other biosimilarnews… MomentaPharmaceuticals, which signed an Abbvie licensing agreement for its biosimilar adalimumab, said in a statement that it will delay FDA filing M923 beyond 2019, which will help reduce its corporate expenditures. This delay should not impact the expected commercial launch date of November 20, 2023, according to the company.

Celltrion announced that it has filed an application for European Medicines Agency approval for its subcutaneous form of its infliximab biosimilar Remsima (US brand name, Inflectra®). This would provide the first subcutaneous injection formulation of infliximab.

Pfizer Receives FDA Rejection on Trastuzumab, Next up Is Amgen/Allergan

When Pfizer announced that it received a complete response letter from the Food and Drug Administration (FDA), the wait for an available biosimilar to Herceptin® just got longer. According to the manufacturer, the FDA specified that the reasons for the rejection of PF-05280014 were not related to clinical questions. The rejection was not associated with manufacturing plant problems, which have tripped up biosimilar manufacturers, including Pfizer, in the past. Instead, the FDA cited the need for additional data related to “technical issues.”

The next potential team up at bat for a trastuzumab biosimilar approval is Amgen and Allergan. A decision on their biosimilar should be rendered before the end of the second quarter. To date, only Mylan/Biocon have obtained approval on this oncologic product (Ogivri™). However, the launch has been delayed by their signing an agreement with Roche, the maker of the reference product. Teva/Celltrion had received a rejection from FDA relating to manufacturing issues in early April, setting back their own marketing timetable.

Even if Pfizer did receive approval at this time, Roche had sued the company in November 2017 for patent infringement. Pfizer had elected to launch at risk with Inflectra®, despite looming legal battles with Janssen over Remicade®, so an immediate launch of their trastuzumab biosimilar could not be ruled out.

Like the situation with pegfilgrastim, gaining competition for trastuzumab is proving frustrating for payers. Obviously, it will occur, but the latest news does not alleviate payers concerns over price increases in the oncology area.