14 Mar 22 | OcyonBio announced that it has entered into a manufacturing and operations agreement with Biosimilar...

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14 Mar 22 | OcyonBio announced that it has entered into a manufacturing and operations agreement with Biosimilar...
03 Mar 22 | US | FDA announced a new funding opportunity for the BsUFA III Regulatory Science Program to support...
We previously wrote that, from 24 March 2022, individuals, businesses and organisations with an Australian presence...
18 Feb 22 | Celltrion released two data sets on the subcutaneous (SC) form of Remsima® (biosimilar infliximab)....
11 Apr 22 | CA | Celltrion announced the launch of Yuflyma® (high-concentration, low-volume, citrate-free and...
07 Feb 22 | The International Generic and Biosimilar medicines Association (IGBA) announced that it has established a...
01 Feb 22 | JAMP Pharma announced the creation of a new division BIOJAMP™ dedicated to biosimilars. The creation of...
Last week we alerted you to the release of a draft new National Medicines Policy (NMP) for public comment. The draft...
On 2 February a draft of a new National Medicines Policy (NMP) was made available for public comment. The draft NMP...
18 Jan 22 | Alvotech announced $21 million in additional commitments for private placement (PIPE) of Oaktree II common...
10 Jan 22 | CA | Alvotech and JAMP Pharma announced that Health Canada has approved Simlandi (high-concentration,...
30 Dec 21 | US | Biocon Biologics announced that the US Court of Appeals for the Federal Circuit Court has upheld the...
Shortly before Christmas, the judgment handed down by Justice Burley on 18 November 2021 on a second preliminary...
20 Dec 21 | US | Sandoz announced that it has submitted a BLA to the FDA for a proposed biosimilar trastuzumab. 20 Dec...
Newly appointed Justice Rofe delivered an early Christmas gift for generic and biosimilar companies in Australia in...
11 Dec 21 | Samsung Bioepis announced that SB12 (proposed eculizumab biosimilar) met all the endpoints in a Ph I...