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Indian drugmaker Biocon says that the US Food and Drug Administration conducted a periodic current Good Manufacturing Practices (cGMP) inspection of its drug substance manufacturing site at Bangalore Campus from September 17 to 21, 2018. 24 September 2018

Copycat specialist Mylan and Fujifilm Kyowa Kirin Biologics have won approval in Europe for their biosimilar version of AbbVie’s Humira (adalimumab), for all indications. 20 September 2018

Several European biosimilar groups have met to discuss key issues affecting the industry at the fourth annual “workshop on biosimilar medicines.” 14 September 2018

Observers are unsure whether to call it a ‘biosame’ or an ‘authorized biosimilar’, but Japanese drugmaker Kyowa Hakko Kirin has had a copy of its own biologic approved in its home country. 17 August 2018

Today, the US Food and Drug Administration finalized the guidance for industry “Labeling for Biosimilar Products.” 18 July 2018

New York’s iBio has inked a deal with CC-Pharming of Beijing, for the joint development of products and manufacturing facilities for the Chinese biopharmaceutical market. 11 July 2018

Amgen has released results from a Phase III study evaluating the efficacy and safety of biosimilar candidate ABP 710 compared with Johnson & Johnson’s Remicade (infliximab) in patients with moderate-to-severe rheumatoid arthritis. 27 June 2018

The US Food and Drug Administration is announcing the availability of a draft guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.” 5 June 2018

The Center for Biosimilars, an online resource for emerging therapies that focuses on improving patient outcomes, launched its latest video interview series featuring Sheila Frame, vice president, head of biopharmaceuticals, North America, Sandoz, a Novartis Division. 1 June 2018

The US Food and Drug Administration (FDA) has announced its new five-part video series, designed to provide an overview of biosimilar and interchangeable products and to highlight key concepts about the development and approval of these products, as well as how state-of-the-art technologies and tools are used to demonstrate biosimilarity. 23 May 2018

YL Biologics, a joint venture between Japan’s Yoshindo and India’s Lupin says the Japanese medicines regulator has accepted and will review an application for YLB113, the firm’s biosimilar of Enbrel (etanercept). 11 May 2018

London-listed Jordanian drugmaker Hikma Pharmaceuticals has signed a licensing agreement with Spanish pharma firm Laboratorios Farmaceúticos Rovi for its enoxaparin sodium biosimilar. 24 April 2018

Pharma company Reig Jofre and biotech LeanBio have announced the launch of Syna Therapeutics. 23 March 2018

Following Turkish approval, received in late January, TRPharm’s lead biosimilar Redditux (rituximab) will shortly be launched in the country for the treatment of non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic lymphoma (CLL). 9 March 2018

Samsung Bioepis has had its Biologics License Application for SB3, a biosimilar referencing Roche’s big-selling cancer drug Herceptin (trastuzumab), accepted by the US Food and Drug Administration. 20 December 2017

The US Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). 1 December 2017

Swiss drugmaker Roche is suing Pfizer, the world’s biggest pharma company, over alleged infringements of patents relating to the cancer drug Herceptin (trastuzumab). 22 November 2017

India’s Biocon and Netherlands-incorporated Mylan have suffered a setback in their bid for US FDA approval for MYL-1401H, the firms’ jointly-developed Neulasta biosimilar. 10 October 2017

The trade group representing manufacturers of generic and biosimilar medicines in Europe has sounded a warning about the ‘unsustainably low’ prices being paid for off-patent drugs that are leading some drugmakers to withdraw from the market and causing shortages of certain products. 29 September 2017

Amgen and Chinese drugmaker Simcere Pharmaceutical Group have signed an exclusive agreement to co-develop and commercialize four biosimilars in China. The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology. 28 September 2017

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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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