BioBlast® w/e 20 May 22

Alvotech’s biosim ustekinumab study results, Samsung Bioepis’ biosim ranibizumab approved in KR, Teva/BioEq’s biosim ranibizumab approved in the UK; Celltrion’s PhIII clinical trial for tocilizumab biosim

by , | May 25, 2022

16 May 22 | Alvotech (Janssen) | AVT04, ustekinumab, (Stelara®)
Alvotech announces study results for AVT04, biosimilar ustekinumab

Alvotech announced positive top-line results from a 3 arm, parallel design study conducted in Australia and New Zealand regarding AVT04 (ustekinumab biosimilar), reporting that the study results demonstrate bioequivalence between AVT04 and Janssen’s Stelara®.  Teva and Stada are Alvotech’s exclusive strategic partners for commercialising AVT04 in the US and EU respectively.

16 May 22 | KR | Samsung Bioepis (Genentech) |Amelivu®, ranibizumab, (Lucentis®)
Samsung Bioepis obtains MA for biosimilar ranibizumab (Amelivu®) in Korea

Korea Biomedical Review reported that Samsung Bioepis has received marketing approval for Amelivu® (biosimilar ranibizumab) in Korea.  Amelivu® will be launched in Korea after June 2022 in accordance with Samsung Bioepis’ licence from Lucentis® developer Genentech.  The Korean Biomedical Review reports that Samsung Bioepis may launch in other licensed regions (which includes the USA) following “after Genentech’s SPC expires”.

17 May 22 | UK | Teva & Bioeq, Genentech | Ongavia®, ranibizumab, Lucentis®
Teva obtains UK approval for Ongavia®, biosimilar ranibizumab

Teva announced that the UK’s MHRA has granted marketing approval for Ongavia® (biosimilar ranibizumab), making the UK the first country in Europe to approve the product for the treatment of (wet) AMD.  Ongavia® will be Teva’s first biosimilar commercialised in Europe, and the UK’s first Lucentis® biosimilar.  The product is the result of a strategic agreement between Teva and Bioeq AG.  Ongavia® is approved for the treatment of: neovascular (wet) age-related macular degeneration; visual impairment due to diabetic macular oedema (DME); proliferative diabetic retinopathy (PDR); visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO); and visual impairment due to choroidal neovascularisation (CNV). 

17 May 22 | KR | Celltrion (Roche) | tocilizumab, (Actemra®)
Celltrion submits clinical trial design for biosimilar tocilizumab in Poland

Korea Biomedical Review reported that Celltrion has submitted a global Ph III clinical trial plan for CT-P47 (biosimilar tocilizumab) to Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.  The global Ph III trial commenced in May 2022, and follows the phase 1 trial which commenced in July 2021

19 May 22 | CA | Biocon & Viatris (Roche/Genentech) | Abevmy®, bevacizumab, Avastin®
Viatris launches Abevmy® (biosimilar bevacizumab) in Canada

Biocon Biologics and Viatris announce the launch of Abevmy® (biosimilar bevacizumab) in Canada.  Abevmy® was jointly developed by Biocon and Viatris, and is indicated for metastatic colorectal cancer, locally advanced, metastatic or recurrent non-small cell lung cancer, platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer and malignant glioma-glioblastoma.  This is the fourth Canadian biosimilar launched by Viatris. 

Under the portfolio development agreement (which includes a “broad portfolio of biosimilars and insulin analogs”), Viatris has exclusive commercialisation rights in the U.S., Canada, Australia, New Zealand, EU and the European Free Trade Association countries, whilst Biocon has them in certain emerging markets.  They share co-exclusive commercialisation rights in the rest of the world.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

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