Under Australian law, patent infringement proceedings may be started in the Australian Federal Court only by a patentee or an exclusive licensee.[1] When it comes to determining th...
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By Naomi Pearce | Feb 11, 2021
Under Australian law, patent infringement proceedings may be started in the Australian Federal Court only by a patentee or an exclusive licensee.[1] When it comes to determining th...
By Naomi Pearce | Feb 09, 2021
TGA has invited submissions on its consultation paper released last Thursday designed to facilitate indication “repurposing”, a phrase coined by TGA to describe the Aust...
By Bioblast Editor | Feb 09, 2021
Lannett announces it has entered into an agreement with the HEC Group of companies for biosimilar insulin aspart. Under the agreement, Lannett will be responsible for funding most of the clinical development requirements, while HEC will continue to develop the product and m...
By Bioblast Editor | Feb 08, 2021
Celltrion announces it has commenced Ph III trials of its proposed aflibercept biosimilar.
By Naomi Pearce | Feb 07, 2021
29 Jan 21 | EU | The CHMP recommended 13 medicines for approval. Among the recommendations were two bevacizumab biosimilars, Mabxience’s Alymsys® and STADA’s Oyavas®.
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By Bioblast Editor | Feb 04, 2021
Roche reports a huge erosion of its year on year CER growth in key areas, attributing this decline to COVID-19 impacts and biosimilars. Roche reported the YoY CER growth of Avastin (bevacizumab) was -25%, with the hematology franchise (including rituximab) at -22% and HER2 ...
By Bioblast Editor | Feb 04, 2021
In an interview with the Centre for Biosimilars the head of Celltrion’s Medical and Marketing Division, HoUng Kim PhD, discussed its high concentration, citrate-free adalimumab biosimilar. Kim announced that Celltrion has completed patent settlements in the US and is ...
By Bioblast Editor | Feb 04, 2021
Enzene Biosciences announces it has received marketing authorisation for its biosimilar teriparatide in India.
By Bioblast Editor | Feb 01, 2021
Coherus Biosciences announces it has reached an agreement with Junshi Biosciences for the development and commercialisation of toripalimab (anti-PD-1 antibody) in the United States and Canada. Toripalimab has received breakthrough therapy designation by the FDA for nasophar...
By Bioblast Editor | Feb 01, 2021
Celltrion announces it has received a notice of compliance from Health Canada for Remsima® SC (subcutaneous infliximab). Remsima® has been approved for the treatment of rheumatoid arthritis.
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