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Medicines regulator Health Canada has granted a notice of compliance (NOC)1 for Herzuma (trastuzumab), biosimilar to Roche’s Herceptin (trastuzumab) in Canada for the treatment of adult patients with early breast and metastatic breast cancer, and metastatic gastric cancer (MGC), the Canadian subsidiary of Israeli drugmaker Teva Pharmaceutical Industries. 11 September 2019

The Malaysian business of India's largest biotech firm Biocon has received a Good Manufacturing Practice (GMP) compliance certificate from the European Medicines Agency (EMA). 22 August 2019

Korean biosimilars company Samsung Bioepis has announced that it has had its Marketing Authorization Application accepted for review by the European Medicines Agency for SB8, a copy of Roche’s cancer drug Avastin (bevacizumab). 19 July 2019

Korean biosimilars company Samsung Bioepis has settled a US patent dispute with Roche’s Genentech, according to Yonhap News Agency. 4 July 2019

Chugai Pharmaceutical says that the Tokyo District Court has rendered judgment dismissing the plaintiff’s claim in the lawsuit filed by Roche subsidiary Genentech wherein the plaintiff demands prohibition against sales etc. of the biosimilar product of anti-CD20 monoclonal antibody Rituxan (rituximab) Injection 10mg/mL by Novartis subsidiary Sandoz KK and Kyowa Hakko Kirin, citing such parties' infringement of three use patents owned by Biogen as the ground. 29 May 2019

Draft guidance has been published on the US Food and Drug Administration’s (FDA) recommendations for the design and evaluation of comparative analytical studies for therapeutic protein biosimilars. 22 May 2019

Mylan will present final data from the HERITAGE study of Ogivri, which is under development in collaboration with Biocon Biologics, at the annual meeting of the American Society of Clinical Oncology (ASCO) later this month. 16 May 2019

Biosimilars

BRIEF—Truxima wins approval in Canada

The Canadian unit of Israeli generics firm Teva Pharmaceutical has been granted approval for its biosimilar product Truxima (rituximab), referencing Rituxan. 15 April 2019

South Korea’s Samsung Bioepis has announced positive data from a three-year follow-up comparing Ontruzant (trastuzumab) with its reference biologic, Herceptin. 22 March 2019

Biosimilars

BRIEF—Napp launches Pelmeg in the UK

Today, Napp Pharmaceuticals, part of the Mundipharma global network of independent associated companies, announced the UK launch of its pegfilgrastim biosimilar Pelmeg. 1 March 2019

Pay-for-delay deals between pharma companies staving off generic competition have become a favorite target for lawmakers eager to be seen combating soaring drug costs. 25 February 2019

Taiwan biotech and contract manufacturing organization (CMO) EirGenix has opened a protein production facility in Hsinchu, Taiwan. 24 January 2019

Taiwan's major biotech manufacturing service provider Mycenax Biotech plans to buy some new drug testing platforms and a small cell strain supplier primarily in the US and Japan in 2019. 24 December 2018

The US Food and Drug Administration approved Herzuma (trastuzumab-pkrb) from South Korean firm Celltrion, as a biosimilar to Herceptin (trastuzumab), marketed by Roche subsidiary Genentech, for patients with HER2-overexpressing breast cancer. 15 December 2018

Japanese drugmaker Daiichi Sankyo has launched the antitumor agent trastuzumab BS for intravenous drip infusions 60mg and 150mg “Daiichi Sankyo” in Japan today. 28 November 2018

Novartis’ US generics business Sandoz was won European approval for the biosimilar Ziextenzo (pegfilgrastim), in the same indications as its reference product, Neulasta. 27 November 2018

Reykjavik-based Alvotech has agreed a commercialization deal with Fuji Pharma to sell its biosimilar portfolio in Japan. 19 November 2018

Mylan and Indian development partner Biocon have launched their biosimilar insulin glargine therapy Semglee, a once-daily, long-acting basal insulin, in the UK. 14 November 2018

Biosimilars

BRIEF—Amgen launches Amgevita in Europe

US biotech major Amgen says that Amgevita, a biosimilar to adalimumab, will launch in markets across Europe beginning today (October 16). 16 October 2018

US pharma giant Merck & Co acknowledged the US Department of Veterans Affairs (VA) for adopting biosimilar medicines as a means of increasing biologic medicine options for Veterans. 9 October 2018

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Sweden-based Xbrane Biopharma and Intas Pharmaceuticals have announced an exclusive global licensing and co-development agreement for the former company’s Opdivo (nivolumab) biosimilar candidate. 20 November 2024

Following US approval in May this year, South Korea’s Samsung Bioepis and US biotech Biogen have now won approval from the European Commission (EC) for their Opuviz 40mg/mL solution for injection in a vial, a biosimilar referencing Regeneron and Bayer’s Eylea (aflibercept). 18 November 2024

South Korean biosimilars company Celltrion today announced its acquisition of iQone Healthcare Switzerland a specialty pharmaceutical company focused on distribution, sales, and marketing in Switzerland. 15 November 2024

Biosimilars

EC approval for Sandoz’s Afqlir

Swiss generic and biosimilar medicines major Sandoz today announced that the European Commission (EC) has granted marketing authorization for Afqlir (aflibercept) 2mg vial kit and pre-filled syringe for intravitreal injection. 15 November 2024

Korean biosimilar company Celltrion is showing that it can also achieve success with a novel biologic. 1 November 2024

The US unit of South Korea-based biosimilar drug developer Celltrion has announced a late-breaking post hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC) of Zymfentra (infliximab-dyyb), during the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. 30 October 2024

Indian drugmaker Biocon subsidiary Biocon Biologicals has released a new extension study evaluating MYL-1701P, a proposed biosimilar to ophthalmic drug aflibercept. 24 October 2024

Iceland-based Alvotech and the US unit of Israel’s of Teva Pharmaceutical Industries today revealed that that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) in a new presentation 22 October 2024

The fully-owned Intas Pharmaceuticals subsidiary Accord Healthcare has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for Imuldosa. 21 October 2024

Celltrion today announced two-year results of subcutaneous infliximab (CT-P13 SC) dose escalation therapy at United European Gastroenterology (UEG) Week 2024 in Vienna, Austria. 15 October 2024

Bio-Thera Solutions and Hungary’s Gedeon Richter have reached an exclusive commercialization and license agreement. 14 October 2024

South Korea’s Samsung Bioepis has released its Fourth Quarter 2024 Biosimilar Market Report, marking the seventh-edition of the Quarterly Biosimilar Market Report in the United States. 11 October 2024

The European Medicines Agency (EMA) has accepted for review the Marketing Authorization Applications for AVT03, a proposed biosimilar candidate to the Prolia and Xgeva (denosumab), submitted by Germany’s STADA Arzneimittel. 10 October 2024

Israel-based Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia (denosumab). 8 October 2024

Israel’s Teva Pharmaceutical Industries and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, have announced a global licensing deal for the development of an anti PD-1 oncology biosimilar candidate. 3 October 2024

European Commission (EC) has issued a marketing authorization for FYB202/Otulfi, a biosimilar to Johnson & Johnson’s Stelara. 27 September 2024

Biosimilars

Coherus shares stumble on supply issue

Californian company Coherus Biosciences has seen its share price tumble by 24% since Friday. 18 September 2024

The Biosimilars Council, alongside the Association for Accessible Medicines (AAM), released its 2024 US Generic & Biosimilar Medicines Savings Report. 6 September 2024

Biosimilar-focused biopharmaceutical company and contract development and manufacturing organization (CDMO) Tanvex BioPharma has named Stephen Lam its new chief executive (CEO). 5 September 2024

Biocon Biologics has signed a settlement and license agreement with Johnson & Johnson that clears the way to commercialize its Bmab 1200, a proposed biosimilar to Stelara (ustekinumab), in Europe, the UK, Canada, and Japan. 3 September 2024

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