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1,629 results found

Article

Pearce IP | Australia | 23 Nov 2020

Pearce IP BioBlast: w/e 20 November 2020

15 Nov 20, US: Genentech filed a complaint against Centus Biotherapeutics, Fujifilm Kyowa Kirin Biologics, Fujifilm Corp and Kyowa Kirin in the…
Article

Pearce IP | Australia | 15 Nov 2020

Pearce IP BioBlast: w/e 13 November 2020

Significant biosimilar activities this week include: 05 Nov 20: Formycon announced its BLA resubmission strategy for FYB201 (proposed ranibizumab…
Article

Herbert Smith Freehills LLP | European Union, United Kingdom | 11 Nov 2020

Consultation on MHRA draft guidance on the licensing of biosimilar products post transition - open until 15 November 2020

From the end of the Brexit transition period (1 January 2020), the licensing of biological products (including biosimilars, advanced therapy…
Article

Bergeson & Campbell PC | USA | 6 Nov 2020

FDA Requests Comments On Reauthorization Of BsUFA

On October 30, 2020, the U.S. Food and Drug Administration (FDA) announced that it will host a virtual public meeting on the reauthorization of the…
Article

Pearce IP | Australia, European Union, United Kingdom | 18 Oct 2020

MHRA Releases Post-Brexit Biosimilar Guidelines

Next year, the UK will conclude its transition from the EU, with the regulation of all medicines and devices to be transferred from EMEA to the UK's…
Article

Pearce IP | Australia | 6 Oct 2020

Pearce IP BioBlast: w/e 02 October 2020

Significant biosimilar activities this week include: 28 Sep 20: Innovent announced its ph III trial of Byvasda® (proposed bevacizumab biosimilar) in…
Article

Pearce IP | Australia, European Union, United Kingdom | 28 Sep 2020

Pearce IP BioBlast: w/e 25 September 2020

Significant biosimilar activities this week include: 21 Sep 20, EU: Alexion announced it has received a positive opinion from the EU's CHMP for a new…
Article

Pearce IP | Australia | 26 Aug 2020

Pearce IP BioBlast: w/e 21 August 2020

11 Aug 20: in an online press conference, Samsung Biologics announced it plans for a fourth manufacturing plant within the year. This new US $2…
Article

Pearce IP | Australia | 17 Aug 2020

Weekly Biosim Update: w/e 14 August 2020

05 Aug 20: in its Q4 FY20 earnings call, Aurobindo Pharma announced that its wholly owned subsidiary CuraTeQ Biologics intends to file applications…
Article

Bergeson & Campbell PC | USA | 7 Aug 2020

FDA DHHS Announces 2021 Biosimilar User Fee Rates

On August 4, 2020, the U.S. Food and Drug Administration (FDA) Department of Health and Human Services (DHHS) announced the rates for biosimilar user…
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