FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. Pursuant to a law enacted in late...more
On March 20, 2023, Coya Therapeutics, Inc. (“Coya”) announced a worldwide agreement with Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”) to license Dr. Reddy’s proposed biosimilar abatacept for the development and...more
On Feb 12, 2023, Biocon Biologics announced that the FDA issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for its biosimilar referencing AVASTIN (bevacizumab), previously submitted by...more
On Jan 6, 2023, Alvotech and Teva announced that the FDA has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to STELARA (ustekinumab), and stated that the companies...more
Alvotech announced yesterday the initiation of a pharmacokinetic study for AVT05, a biosimilar referencing Johnson & Johnson’s (“J&J”) SIMPONI and SIMPONI ARIA (golimumab). SIMPONI is used to treat certain types of...more
On Jan 9, Coherus BioSciences, Inc. (“Coherus”) announced that it has agreed to acquire the exclusive commercialization rights to FYB203, a biosimilar referencing EYLEA (aflibercept) from Klinge Biopharma GmbH (“Klinge...more
According to PwC, “2022 has been a challenging year for M&A in the pharmaceutical and life sciences sector, with both deal value and volume at multiyear lows thanks to overall macro headwinds coupled with broad-based market...more
Alvotech announced yesterday the launch of HUKYNDRA, a high-concentration, low-volume, citrate-free biosimilar to HUMIRA (adalimumab), in Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia....more
Last week, AbbVie held its third quarter 2022 earnings conference call, which included considerable discussion of forthcoming competition with biosimilars to HUMIRA (adalimumab) in 2023....more
On Sep 16, 2022, Partners STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (publ) (“Xbrane”) announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a...more
Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD). Teva entered into a strategic...more
8/30/2022
/ Biologics ,
Biosimilars ,
Celltrion ,
European Commission ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Marketing Authorization Application ,
Pharmaceutical Industry ,
Regulatory Approval ,
Sandoz ,
Teva Pharmaceuticals
Alvotech announced this week the initiation of a confirmatory patient study for AVT03 (denosumab), a biosimilar candidate to PROLIA® and XGEVA®, to demonstrate clinical similarity to PROLIA® in terms of efficacy,...more
The FDA is hosting a virtual public workshop on September 19, 2022 on “Increasing the Efficiency of Biosimilar Development Programs.” The workshop will focus on comparative clinical studies and “discuss possible...more
Sandoz announced this week that the U.S. Food and Drug Administration (FDA) has accepted the first-ever biologics license application (BLA) for a proposed natalizumab biosimilar to Biogen’s TYSABRI®. The proposed natalizumab...more
Alvotech, a global biotech company focused solely on the development and manufacture of biosimilar medicines announced yesterday that its ordinary shares and warrants will begin trading on Nasdaq today, June 16, under the new...more
Organon announced yesterday that it has entered into an agreement with Henlius, whereby Organon will license commercialization rights for biosimilar candidates referencing PERJETA® (pertuzumab) and PROLIA®/XGEVA®...more
Below are some highlights from first quarter 2022 earnings reports recently released by biologics and biosimilars companies:
Biogen: Last week, Biogen reported total quarterly revenues of $2,532 million, and biosimilar...more
Shanghai Henlius Biotech, Inc. (“Henlius”) announced this week that it has entered into a license and collaboration agreement with Eurofarma Laboratórios SA (“Eurofarma”), a Brazilian multinational biopharmaceutical company,...more