Amneal announced the FDA has accepted the BLA for Alymsys™ (proposed bevacizumab biosimilar). Alymsys™ was developed in collaboration with mAbxience.
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By Bioblast Editor | Jun 17, 2021
Amneal announced the FDA has accepted the BLA for Alymsys™ (proposed bevacizumab biosimilar). Alymsys™ was developed in collaboration with mAbxience.
By Naomi Pearce | Jun 15, 2021
07 Jun 21 | Celltrion launched Remsima SC® (subcutaneous infliximab biosimilar) in Canada. Remsima SC® is indicated for the treatment of rheumatoid arthritis.
07 Jun 21 | Merck r...
By Bioblast Editor | Jun 15, 2021
Alvotech announced it has reached the primary completion date in its switching study for AVT02 (proposed adalimumab biosimilar). Alvotech hopes to list AVT02 as an interchangeable adalimumab biosimilar in the US, which would allow for pharmacy substitution.
By Pearce IP | Jun 15, 2021
In September 2020, Pearce IP reported on a significant Australian Patent Office decision, which held that a patent term extension (PTE) request must be based on the first regulatory...
By Bioblast Editor | Jun 12, 2021
Celltrion presented data for Truxima® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress. Celltrion reported that the response rates, survival rates and overall safety profile of Truxima® appeared consistent with those rep...
By Pearce IP | Jun 12, 2021
Pearce IP is proud that its patent practitioners feature again in the Managing IP Awards 2021. Congratulations to Naomi Pearce, Principal Lawyer, Patent Attorney and Trade Mark Att...
By Pearce IP | Jun 11, 2021
Pearce IP recently reported on recommendations made by an independent review into the Australian patent system to overhaul the way in which patent litigation proceeds in Australia. ...
By Naomi Pearce | Jun 11, 2021
Date: 11 June 2021Court: Federal Court of AustraliaJudge: Beach J
Background
Under Australian law, patents that cover certain pharmaceutical inventions are eligible for...
By Bioblast Editor | Jun 10, 2021
Theramex UK announced it has entered into an agreement with Enzene Biosciences for the commercialisation of a biosimilar denosumab. Under the agreement, Enzene will supply Theramex with the product for commercialisation in Europe, the UK, Switzerland and Australia.
By Bioblast Editor | Jun 10, 2021
The UK’s NICE published final draft guidance recommending adalimumab, etanercept and infliximab for the treatment of moderate rheumatoid arthritis on the NHS. Previously, biologics had been recommended only for severe rheumatoid arthritis.
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