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Australia’s TGA approved Cipla/Alvotech’s 100mg/mL adalimumab biosimilar AVT02 (Ciptunec®/Ardalicip®) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis, an...

German based biosimilars focussed company Formycon published its preliminary and unaudited financial results for the first half of 2022.  Formycon reported a turnover of Euro 17.6 million in the first six months of 2022.  The preliminary report does not include the purchase...

Significant biosimilar activities this week include:

12 Aug 22 | US | Alvotech, Mylan & others file amicus curiae briefs in support of Teva’s skinny label case

Alvotech, Mylan, the Association for Accessible Medicines, and 42 professors of law, economics, ...

Alvotech announced that it has received a complete response letter from the FDA in relation to its BLA for AVT02 (biosimilar adalimumab).  Alvotech anticipates being launch ready by the expected US launch date of 1 July 2023 .

In this PiPCast™, we discuss whether a patent inventor must be human or can include artificial intelligence systems in Australia, and look to the future legal developments in this space.

The FDA approved Fresenius Kabi’s Stimufend® (biosimilar pegfilgrastim).  Stimufend is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated w...

Prestige Biopharma announced that it will acquire more shares of Prestige Biologics, to secure a total of 24.88% of the CDMO company.  Prestige Biopharma reported that the new structure will allow the group to establish a full value chain with a 154,000 L, global-scale prod...

Alvotech published its first half 2022 financial results, reporting a revenue growth to over $40 million compared to $2.0 million in the first half of 2021 due to recent launches of adalimumab (AV02) in Canada and Europe.  The company has $128.4Min cash/equivalents and has ...

Biocon Biologics announced that the FDA has issued 17 observations following its inspection of Biocon’s manufacturing facilities in Bengalaru, India (11 observations) and Johor, Malaysia (6 observations) relating to pre-approval inspections for bevacizumab, rh-Insulin and i...

The PTAB instituted Celltrion’s two inter partes reviews (IPRs) of Chugai and Roche’s tocilizumab patents 8,580,264 and 10,874,677.  The IPRs were instituted on each of the grounds in Celltrion’s petition.