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Recent BioBlast® Updates

New Indication Alert: MSD’s Keytruda® Obtains Approval for Cervical Cancer Indication in Korea

Apr 16, 2024

The Korea Biomedical Review reports that, on 16 April 2024, Merck Sharp & Dohme (MSD) announced that it obtained approval in Korea for an expanded indication for its Keytruda® (pembrolizumab) as a combination therapy with chemoradiotherapy for treating FIGO...

Fresenius Launches Biosimilar Tocilizumab in the US

Apr 15, 2024

On 15 April 2024, Fresenius Kabi announced its US launch of Tyenne® (tocilizumab-aazg), biosimilar to Roche’s Actemra® (tocilizumab) in an intravenous formulation. Both IV and subcutaneous forms of Tyenne were FDA approved on 5 March 2024. Tyenne is the third...

Celltrion Presents Phase 3 Results for Denosumab Biosimilar

Apr 15, 2024

The Korea Times reports that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to Amgen’s Prolia® (denosumab), at the World Congress on Osteoporosis held in London from 11-14 April 2024. It is reported that the clinical trial showed...

Aflibercept Appeals Dismissed for Lack of Jurisdiction

Apr 12, 2024

As previously reported, on 27 December 2023, and in a judgment published on 31 January 2024, the US District Court for the Northern District of West Virginia held that Mylan and Biocon infringed eight claims of Regeneron’s US patent 11,084,865, in respect of...

Six Regeneron Aflibercept US Patent Infringement Actions to be Centralized in West Virginia

Apr 12, 2024

On 11 April 2024, the United States Judicial Panel on Multijurisdictional Litigation ruled that patent infringement actions brought by Regeneron regarding aflibercept biosimilars by Amgen, Mylan, Celltrion, Samsung Bioepis (2 actions) and Formycon involved “common...

Approval Alert: Samsung Bioepis First Korean Approved Ustekinumab Biosimilar

Apr 12, 2024

On 12 April 2024, Korea Biomedical Review reported that Samsung Bioepis received Korean approval for EpyztekTM(SB17), biosimilar to Janssen’s Stelara® (ustekinumab), for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. ...

Formycon AG & Bioeq AG Launch Lucentis® (ranibizumab) Biosimilar in Canada and Switzerland

Apr 11, 2024

On 11 April 2024, Formycon AG and Bioeq AG announced the launch of Lucentis® (ranibizumab) biosimilar FYB201 in Canada and Switzerland. Health Canada granted marketing authorization under the tradename RanoptoTM, and Swissmedic has approved FYB201 under the...

Celltrion Obtains US Formulation Patent for Subcutaneous Infliximab (Zymfentra®)

Apr 11, 2024

On 11 April 2024, Business Korea published that Celltrion has been granted a formulation patent (US 11 951 207) for its ZYMFENTRA®. ZYMFENTRA® is the world's first self-developed subcutaneous injection of infliximab for treating autoimmune diseases. Celltrion claims...

Ginkgo Bioworks to Improve Novo Nordisk’s Chronic Disease Medications Manufacturing Over 5 Years

Apr 10, 2024

Boston-based Ginkgo Bioworks announced on 10 April 2024 an expansion of its partnership with global healthcare leader, Novo Nordisk. This extended collaboration, set to span five years, is targeting improving the manufacturing of Novo Nordisk's medicines with a focus...

Genentech & Dr Reddy’s Settle US Rituximab Dispute

Apr 10, 2024

On 10 April 2024, as a result of a settlement between the parties, the US District Court for the District of New Jersey dismissed all patent infringement claims in the proceeding brought by Genentech, Hoffmann-La Roche and Biogen against Dr Reddy’s Laboratories and...

Samsung Bioepis Releases Fifth Biosimilar Market Report: Adalimumab Biosimilar Uptake at 4% Following First Year of Biosimilar Competition

Apr 8, 2024

On 8 April 2024, Samsung Bioepis released its fifth US Biosimilar Market Report. The quarterly report details average sales price information for US launched biosimilars and market share and price trends. The Q2 2024 Report notes that as of April 2024, the FDA has...

Approval Alert: Mabwell’s MAIWEIJIAN™ is First Chinese Approved Denosumab Biosimilar

Apr 8, 2024

On 8 April 2024, PR Newswire reported Mabwell’s MAIWEIJIANTM (denosumab 120mg) (biosimilar to Amgen’s Xgeva®) received marketing approval in China. MAIWEIJIAN was developed by Mabwell’s wholly owned subsidiary T-mab. It is approved in China for the treatment of...

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Recent BioBlast® Updates

New Indication Alert: MSD’s Keytruda® Obtains Approval for Cervical Cancer Indication in Korea

Fresenius Launches Biosimilar Tocilizumab in the US

Celltrion Presents Phase 3 Results for Denosumab Biosimilar

Aflibercept Appeals Dismissed for Lack of Jurisdiction

Six Regeneron Aflibercept US Patent Infringement Actions to be Centralized in West Virginia

Approval Alert: Samsung Bioepis First Korean Approved Ustekinumab Biosimilar

Formycon AG & Bioeq AG Launch Lucentis® (ranibizumab) Biosimilar in Canada and Switzerland

Celltrion Obtains US Formulation Patent for Subcutaneous Infliximab (Zymfentra®)

Ginkgo Bioworks to Improve Novo Nordisk’s Chronic Disease Medications Manufacturing Over 5 Years

Genentech & Dr Reddy’s Settle US Rituximab Dispute

Samsung Bioepis Releases Fifth Biosimilar Market Report: Adalimumab Biosimilar Uptake at 4% Following First Year of Biosimilar Competition

Approval Alert: Mabwell’s MAIWEIJIAN™ is First Chinese Approved Denosumab Biosimilar

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