Tag: Biosimilars

EMA and European Commission published new information on biosimilars

The European Medicines Agency and the European Commission have published material on biosimilar medicines, as part of their collaboration to improve understanding of biosimilars.

Pall Biotech to collaborate with Aetos Biologics

Pall Corporation has announced a strategic partnership between its Pall Biotech business unit and Aetos Biologics, a biosimilar cell line development company.

GeneSys Biologics launches an integrated drug development facilty

GeneSys Biologics, an Indian biotechnology company based in Hyderabad, launched its integrated drug development facility in Genome Valley, Shameerpet (India).

BIOCAD’s biosimilar of darbepoetin alfa will be available at the end of 2018

BIOCAD announced the completion of clinical trials for the first Russian-made biosimilar of darbepoetinalfa (BCD-066), which was designed to treat anemia related to chronic kidney disease or cancer.

Prestige BioPharma and Alvogen will launch Trastuzumab biosimilar in Europe

Prestige BioPharma and Alvogen announced that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Trastuzumab biosimilar in Central and Eastern Europe.

Lupin and Mylan will commercialize Etanercept

Pharma major Lupin Limited and global pharmaceutical company Mylan N.V. announced that the two companies will partner to commercialize a biosimilar to Enbrel® (Etanercept).

LG Chem start to market etanercept biosimilar in Japan

LG Chem Ltd., South Korea's leading chemical company, begun selling its biosimilar etanercept for the treatment of rheumatoid arthritis in Japan.

EU Commission offers a proposal to adjust intellectual property rules

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The EU Commission proposed to adjust intellectual property rules to help Europe's pharmaceutical companies tap into fast-growing global markets and foster jobs, growth and investments in the EU.

Russian biosimilar of rituximab was approved for registration in Cuba

Cuban Ministry of Health (CECMED) approved for registration the biosimilar of rituximab manufactured by BIOCAD, a Russian biotech company. Supplies of this drug to Cuba are scheduled for the end of 2018.

Catalent and Valerius will collaborate on biosimilars

Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, and Valerius Biopharma AG, a Swiss biopharmaceutical company.

AbbVie reached a resolution in intellectual property-related dispute

AbbVie announced it reached a global resolution for all intellectual property-related litigation with the two companies regarding its biosimilar Imraldi (adalimumab).

Samsung Bioepis biosimilar cancer drug begun to sell in Europe

Korean biopharmaceutical firm Samsung Bioepis informed that its biosimilar cancer drug Ontruzant has begun selling in Britain following approval from a European regulator (EMA).

Russia registers its first domestically manufactured biosimilar of infliximab

The Russian Ministry of Health has registered BCD-055, the first Russian-made biosimilar of infliximab developed by BIOCAD, a biotech company. BIOCAD was developing the local biosimilar of infliximab since 2013.

Sandoz and Biocon partnered to develop multiple biosimilars

Sandoz, a Novartis division, announced a global partnership with Asia's premier biopharmaceuticals company, Biocon, to develop, manufacture and commercialize multiple biosimilars

Russian biosimilar of adalimumab fully confirmed its equivalence

BIOСAD has successfully completed the main stage of clinical trials for the Russian biosimilar of adalimumab, a drug for the treatment of autoimmune and chronic inflammatory diseases

Samsung Bioepis received EU approval for its Herceptin biosimilar

Samsung Bioepis announced the European Commission’s marketing authorization of ONTRUZANT, a biosimilar referencing Herceptin (trastuzumab)