Showing 15 posts of 87 posts found.


Samsung Bioepis takes AbbVie to court over attempts to delay Humira biosimilars

April 5, 2016
Manufacturing and Production, Research and Development, Sales and Marketing AbbVie, Biogen, Humira, Samsung Bioepis, biosimilars, rheumatoid arthritis

Samsung Bioepis has filed a lawsuit against Abbvie (NYSE: ABBV) to stop the maker of the world’s bestselling drug Humira …


FDA releases biosimilars labelling guidance

April 1, 2016
Manufacturing and Production, Medical Communications, Research and Development FDA, biosimilars

The US Food and Drug Administration (FDA) has issued draft guidance on the labelling of biosimilar drugs. The guidance states …


Samsung Bioepis’ Remicade biosimilar set for CHMP verdict

March 31, 2016
Medical Communications, Sales and Marketing Flixabi, Remicade, Samsung Bioepis, biosimilars, infliximab

Samsung Bioepis has confirmed that the European Commission’s scientific committee, the CHMP, is this week discussing the approval of its …


Biosimilars could save healthcare systems $100bn by 2020

March 30, 2016
Research and Development, Sales and Marketing biosimilars

The growth of the market for biosimilar drugs has the potential to save EU and US healthcare systems up to …


Amgen sues Novartis over Enbrel biosimilar

March 3, 2016
Research and Development, Sales and Marketing Amgen, Novartis, Sandoz, biosimilars

Amgen has filed a suit in a US court against Novartis’ generics unit Sandoz, in a bid to protect bestselling …


Merck begins late-stage trials of Humira biosimilar

March 2, 2016
Research and Development, Sales and Marketing AbbVie, Humira, Merck, biosimilars

Merck has announced the beginning of a global phase III study of its Humira (adalimumb) biosimilar, MSB11022, in chronic plaque …


Biosimilars: Can the US catch up in 2016?

February 12, 2016
Medical Communications, Sales and Marketing Eli Lilly, Enbrel, FDA, Neulasta, Novartis, Pfizer, Sandoz, Zarxio, biosimilars

What are biosimilars? Biosimilars are essentially the biological equivalent of generic drugs to their branded small-molecule counterparts (what Ibuprofen is …


Sandoz buys rights to Pfizer biosimilar

February 12, 2016
Medical Communications, Research and Development, Sales and Marketing Pfiizer, Sandoz, biosimilars

Sandoz has announced further expansion to its biosimilars programme with the acquisition of the European rights to Pfizer’s Remicade (infliximab) …


Sandoz’s Carol Lynch elected to chair European Biosimilars Group

February 10, 2016
Medical Communications biosimilars

The European Generic Medicines Association (EGA) has elected Carol Lynch, global head of Biopharmaceuticals & Oncology Injectables at Sandoz, as …


FDA set to approve Remicade biosimilar

February 9, 2016
Manufacturing and Production, Research and Development, Sales and Marketing Remicade, biosimilars, remsima

An FDA committee has had some positive words for Celltrion’s biosimilar candidate to Janssen/MSD’s Remicade (infliximab), concluding that the copycat biologic …

NICE backs biosimilars with arthritis drug endorsements

January 27, 2016
Research and Development, Sales and Marketing DMARDs, NICE, biosimilars, rheumatoid arthritis

NICE has published updated final guidance recommending seven biological disease modifying drugs (DMARDs) for treatment of severe rheumatoid arthritis which …

Mylan building

Mylan announces Momenta collaboration to develop six biosimilars

January 8, 2016
Manufacturing and Production, Sales and Marketing Heather Bresch, Momenta, Mylan, biosimilars

Mylan has entered an exclusive global collaboration agreement with Momenta Pharmaceuticals, to develop, manufacture and commercialise six of Momenta’s biosimilar …

EMA inside

Sandoz announces biosimilar successes

December 8, 2015
Manufacturing and Production American Society of Hematology, Enbrel, Neulasta, Sandoz, ash, biosimilars, etanercept, pegfilgrastim

Novartis’ biosimilars division Sandoz has announced progress in its biosimilars programme, with its version of Amgen’s Neulasta proving as effective …

Europe Member State flags

EU plans export waiver for pharma manufacturing

November 3, 2015
Manufacturing and Production EGA, European Commission, biologics, biosimilars, generics, manufacturing, supplementary protection certificates

The European Commission plans to bring in an export waiver for supplementary protection certificates, in order to boost pharma industry …

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