Embroiled in patent litigation, the partnership of Amgen and Allergan have waited for the opportunity to launch Mvasi® since September 2017. During this time, the competition has not been stagnant, with Pfizer moving towards an FDA decision. The next 6 months may prove critical, but when will providers, patients, and payers have access to Avastin® … Continue reading An Update on Potential Biosimilars for Bevacizumab
Tag: Pfizer
Coauthor of Hatch–Waxman Act Attacks the Use of IPR Process for Biosimilars
The Hatch–Waxman Act (officially, The Drug Price Competition and Patent Term Restoration Act of 1984) enabled generic medications to be marketed after branded patent expirations. One of the bill’s cosponsor, Senator Orrin Hatch (R-UT), is now spurring a legislative proposal that would protect reference drug manufacturers from use of the inter partes review (IPR) system. … Continue reading Coauthor of Hatch–Waxman Act Attacks the Use of IPR Process for Biosimilars
Pfizer Pulls One Biosimilar Adalimumab Application From the EMA
Earlier this month, Pfizer notified the European Medicines Agency (EMA) that it was withdrawing one of its two applications for approval of its biosimilar adalimumab. According to Pfizer's Director of Global Media Relations, Thomas Biegi, the company had submitted two applications for this biosimilar, one for a limited set of indications, and the other for … Continue reading Pfizer Pulls One Biosimilar Adalimumab Application From the EMA
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 … Continue reading Pfizer Signs Licensing Agreement With Roche on Trastuzumab Biosimilar
Pfizer Launches Retacrit, First Biosimilar Version of Epogen and Procrit
On November 13, Pfizer began marketing its biosimilar version of epoetin alfa. Pfizer launches Retacrit® at a 33.5% discount to Amgen’s reference product Epogen®. Retacrit was originally developed by Hospira, which Pfizer acquired in 2015. Retacrit was one of the first biosimilars approved in the EU. It had a long journey to reaching the market in … Continue reading Pfizer Launches Retacrit, First Biosimilar Version of Epogen and Procrit
Pfizer’s Anticompetitive Suit: A Slippery Slope to Competitive Bidding?
When Pfizer first announced its lawsuit against Janssen’s parent Johnson & Johnson in September 2017, it pointed to exclusionary contracting, “anticompetitive" behavior of Remicade®’s maker as the reason for its very limited market access. The lawsuit claimed that Janssen has withheld or threatened to withhold rebates if payers do not keep Remicade in an exclusive … Continue reading Pfizer’s Anticompetitive Suit: A Slippery Slope to Competitive Bidding?
Biosimilars and Drug Rebates: A Foot in the Door to Access?
At the September 5–7, 2018 GRx+Biosims meeting, I had the opportunity to moderate a session with three highly experienced biosimilar industry executives. They included Gary Deeb, Senior Vice President, Global Licensing and Business Development, Lupin Pharmaceuticals; Chrys Kokino, MBA, Head Global Biologics— Commercial, Mylan; and Mike Woolcock, MBA, Senior Vice President, Commercial Operations, Apobiologix. In … Continue reading Biosimilars and Drug Rebates: A Foot in the Door to Access?
Pfizer Gets FDA’s Green Light on Its Filgrastim Biosimilar
On July 20, the US Food and Drug Administration (FDA) approved the second biosimilar version of filgrastim. Pfizer's filgrastim biosimilar is named Nivestym™ (filgrastim-aafi). The originator product, Amgen’s Neupogen®, has steep competition from two other products (Sandoz’s Zarxio® [filgrastim-sndz] and Teva’s Granix® (tbo-filgrastim]). Granix was approved as a follow-on biologic, before the biosimilar pathway was … Continue reading Pfizer Gets FDA’s Green Light on Its Filgrastim Biosimilar
Infliximab Biosimilars Savings Could Exceed $400 Million Dollars Annually
Everyone with an opinion believes that biosimilar drug use will save the health system considerable money. Calculations for biosimilar savings have been hampered by several factors. For example, previous high estimates have not been based on real-life scenarios. Only 3 biosimilars have been launched and utilized in the US; so little experience has been gained on which … Continue reading Infliximab Biosimilars Savings Could Exceed $400 Million Dollars Annually
FDA Advisory Committees on Biosimilar Applications: Mylan’s Latest Muddies the Waters Further
When the Food and Drug Administration (FDA) approved the first biosimilar pegfilgrastim (Mylan’s Fulphila™), it broke precedent in more ways than one. Not only was this the first biosimilar member of the pegfilgrastim class to be approved, but its approval did not require an FDA Advisory Committee recommendation. The FDA has been a bit fuzzy … Continue reading FDA Advisory Committees on Biosimilar Applications: Mylan’s Latest Muddies the Waters Further