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India’s Biocon Biologics has launched a new outreach initiative in diabetes, together with Asia’s largest research and professional organization for the therapy area, the Research Society for the Study of Diabetes in India (RSSDI). 15 November 2021

A biosimilar epilepsy treatment, CannEpil+, has been approved for import into the UK. The therapy will be made available for free on compassionate grounds to ten patients for six months, as part of the clinical trial process. 13 September 2021

Samsung Bioepis has announced results from a post-hoc and subgroup analysis of a Phase III study of Byooviz (ranibizumab) in neovascular age-related macular degeneration (nAMD). 9 September 2021

China is about to approve the country's first biosimilar of Amgen's Xgeva (denosumab), which is indicated for the prevention of skeletal-related events in people with bone metastases from solid tumors and in patients with multiple myeloma. 1 September 2021

Biosimilars

BRIEF—New home for Samsung Bioepis

Samsung Bioepis, Korea’s joint venture between Samsung Biologics and Biogen that has become a leader in the global biosimilars market, has opened its new headquarters. 25 January 2021

India’s Biocon Biologics has received a primary equity investment from Abu Dhabi-based ADQ, one of the region’s largest holding companies, worth $75 million. 7 January 2021

The biologics subsidiary of Indian generics company Biocon has received a $150 million capital injection from investment bank Goldman Sachs, subject to customary approvals and conditions. 9 November 2020

Luye Pharma’s biotech subsidiary Boan has licensed LY9004, a biosimilar version of Regeneron and Bayer’s Eylea (aflibercept), to the Chinese ophthalmic drug company Ocumension. 30 October 2020

Taiwan generics and biosimilars supplier Lotus Pharm (a subsidiary of privately-owned US drugmaker Alvogen) signed a licensing deal with the South Korean pharma Chong Kun Dang (CKD) Pharmaceutical. 18 September 2020

Indian drugmaker Lupin and Netherlands-based Mylan have announced the launch of Nepexto, a biosimilar of Amgen’s Enbrel (etanercept), in the German market. 27 August 2020

Mylan and Fujifilm Kyowa Kirin Biologics today announced that the US Food and Drug Administration has approved Hulio (adalimumab-fkjp), a biosimilar to AbbVie's Humira (adalimumab). 9 July 2020

Chinese insulin supplier Gan & Lee Pharmaceutical aims to go public soon in Shanghai Stock Exchange's STAR market, which mimics Nasdaq to attract Chinese innovative companies in the science and technology sector. 9 June 2020

Biosimilars

BRIEF—Fulphila launches in Australia

India’s Biocon and USA-based Mylan have launched Fulphila, a biosimilar to Neulasta (pegfilgrastim), in Australia. 14 April 2020

Japanese drugmaker Daiichi Sankyo has launched a biosimilar product in its home country referencing the Roche cancer drug Avastin (bevacizumab). 19 December 2019

A European trade group has used the publication of an official report to highlight the important role of biosimilar medicines. 28 November 2019

Samsung Bioepis has announced that the US Food and Drug Administration has accepted for review the its Biologics License Application (BLA) under the 351(k) pathway for SB8, a biosimilar candidate referencing Avastin (bevacizumab). 19 November 2019

The world’s biggest pharma company became the latest drugmaker to gain US Food and Drug Administration approval for a biosimilar version of the world’s biggest-selling drug. 19 November 2019

India’s Biocon has received an Establishment Inspection Report (EIR) from the US regulator for its biologics factory in Bengaluru. 6 November 2019

Many European countries are grappling with the efficiency of hospital care, which is facing growing demands from an increasingly elderly population. The optimal use of generic, biosimilar and value-added medicines is one major contributor to this efficiency. 8 October 2019

The value added medicines sector group of Medicines for Europe welcomes the publication from industry analyst IQVIA’s Thought Leadership “A Digital Future for Value Added Medicines.” 25 September 2019

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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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