Below are some highlights of recent news in biosimilar and follow-on biologic development: Prestige BioPharma On July 2, Prestige BioPharma (Prestige) licensed the rights to Tuznue, its trastuzumab biosimilar of Roche’s Herceptin, to Mundipharma in selected European markets. The European Medicines Agency (EMA) recently accepted a Marketing Authorisation Application for…
On June 28, 2019, Samsung Bioepis and Genentech filed a joint stipulation of dismissal of their BPCIA patent litigation concerning ONTRUZANT (trastuzumab-dttb), Samsung Bioepis’s biosimilar of HERCEPTIN that received FDA-approval earlier this year. According to the stipulation, the parties “have entered into a settlement agreement, and mutually agree to voluntarily dismiss…
Below are some highlights of recent news in biosimilar and follow-on biologic development: On June 14, Sandoz announced positive clinical study data regarding HYRIMOZ, its biosimilar of HUMIRA (adalimumab). According to Sandoz’s press release, data from a 48-week phase 3 clinical study demonstrated that switching from HUMIRA to HYRIMOZ provides…
Today, June 13, 2019, the U.S. FDA approved Amgen’s aBLA for KANJINTI (trastuzumab-anns), a biosimilar of Genentech’s HERCEPTIN. According to its approved package insert, KANJINTI, like its reference product, is indicated for the treatment of HER2 overexpressing breast cancer and the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction…
A recent analysis reveals that prescription drug prices continue to increase — even for drugs with FDA-approved therapeutic equivalents or biosimilar products. Dr. Nathan Wineinger evaluated the change in prescription drug prices over a 6-year period for the 49 top-selling brand-name medications in the United States. The price of 48…
On May 9, 2019, U.S. Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT) announced that they had introduced the Affordable Prescriptions for Patients Act. According to the sponsors’ press release, the bill is designed to prevent “product hopping and patent thicketing within the Federal Trade Commission (FTC) Act.” In the…
Lupin recently announced approval in Japan to manufacture and sell an etanercept biosimilar, YLB113. YLB113 is approved to treat moderate to severe rheumatoid arthritis and juvenile idiopathic arthritis. YLB113 will be marketed in Japan by a joint venture between YL Biologics Limited and a Lupin subsidiary. This marks Lupin’s first…
Earlier this month, a bipartisan group of six senators introduced the Biologic Patent Transparency Act (“BPTA”), which the senators say will “help increase patent transparency, promote biosimilar competition, bring needed biosimilar treatments to patients faster, and ultimately, lower drug prices for consumers.” The sponsors further state that the bill will…
As we previously reported, in October 2018, Genentech brought claims against Taiwan-based biosimilar developer JHL Biotech, Inc. and individual defendants for trade secret misappropriation, computer fraud, breach of contract, and other claims. The alleged trade secrets relate to several of Genentech’s products: Rituxan® (rituximab), Herceptin® (trastuzumab), Avastin® (bevacizumab), and Pulmozyme®…
We are excited to share a video produced in collaboration with Bristows LLP focused on the areas of biosimilars litigation and regulation in the U.S. and EU/UK. In this video , Overview of Differences Between Governing Schemes for Biosimilars, Dom Adair, Partner at Bristows and Rob Cerwinski, Partner at Goodwin…