Shanghai Henlius Biotech, Inc. (2696.HK), a leading biopharmaceutical company in China focusing on oncology and autoimmune diseases, won the award of "Biosimilar Initiative of the Year" (HLX01, rituximab injection) and was also shortlisted for the award of "the Company of the Year, Asia-Pacific" at the 6th Global Generics & Biosimilars Awards 2019 ceremony held on 5 November 2019 in Frankfurt, Germany, which makes Henlius the first Chinese enterprise to clinch the award.
Bioeq IP AG ("Bioeq") today announced that it signed a license and development agreement with Coherus BioSciences, Inc. ("Coherus"Nasdaq:CHRS), under which Coherus will exclusively market and distribute Bioeq's biosimilar candidate to Lucentis® (ranibizumab) in the United States (U.S.)
andoz, a Novartis division and a global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar ZiextenzoTM (pegfilgrastim-bmez). Sandoz biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo® (pegfilgrastim) since 2018. Sandoz now intends to launch Ziextenzo in the US as soon as possible this year.
Biocon Ltd, an innovation-led global biopharmaceuticals company, recently announced that it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its Biologics Drug Product facility in Bengaluru, stating the inspection is closed. This reaffirms Biocon Biologics’ global scale manufacturing capability for high quality, affordable biosimilars for the U.S. market.
Biologics used to treat patients can be incredibly expensive, so there was significant hope that biosimilar drugs — which are highly similar to an existing biologic drug on the market — could serve as a less-costly substitute.
Biopharmaceutical company Alvotech announced recently that Abu Dhabi-based investment company, Yas Holding, has acquired a 2.5% stake in their business and signed an agreement for the exclusive partnership and supply of three Alvotech biosimilar candidates, which Yas Holding will commercialize in the MENA region.
Ascentage Pharma (6855.HK), a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, hepatitis B virus and age-related diseases, today announced a combination therapy strategic collaboration with Henlius (2696.HK), working together to conduct clinical trials of the combination therapy between APG-2575, a novel, orally administered Bcl-2 selective inhibitor developed by Ascentage Pharma, and HLX01 (Rituximab Injection), the first launched product by Henlius, for the treatment of chronic lymphocytic leukemia (CLL) in the People's Republic of China.
Amgen, one of the world's leading biotechnology companies, launches its first biosimilar for cancer treatment in the Brazilian market. KANJINTI™ (trastuzumab) has been approved by ANVISA (National Health Surveillance Agency) after passing tests that have proven its biosimilarity to Herceptin® .
CPhI Worldwide– the world’s largest pharma event, taking place in Frankfurt, Germany (5-7 November, 2019) – releases the second part of its annual report focussed on biologicals.
Formycon AG recently announced the start of a Phase I clinical trial comparing the pharmacokinetics, safety, and tolerability of FYB202 and the reference product Stelara (USA / EU). Dosing of study subjects started last week.
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