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Prescription Drugs Japan

Goodwin

Biosimilars Licensing Agreement Updates

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Earlier this week, Biocon Biologics Ltd. announced that it has entered into a strategic out-licensing agreement with Yoshindo Inc. to commercialize ustekinumab and denosumab biosimilars for the Japanese market. Pursuant to...more

Goodwin

International Biosimilar Approval and Launch Updates

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On November 25, 2021, Japan-based Mochida Pharmaceutical Co. announced that its adalimumab biosimilar, Adalimumab BS MA, had been launched in Japan following the listing of the drug on the National Health Insurance. According...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – June 2021

Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an article on managing IP development and capture at growing medtech start-ups that offers insight from executives at...more

Goodwin

Alvotech and Fuji Pharma Announce Continued Biosimilar Partnership in Japan

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Fuji Pharma and Alvotech announced their agreement to extend the companies’ exclusive partnership for the commercialization of four biosimilar medicines in Japan. We previously posted on that partnership when it was first...more

Hogan Lovells

Coronavirus: The Hill and the Headlines – COVID-19 D.C. Update – September 2020 # 3

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In Washington - Senate Majority Leader Mitch McConnell (R-KY) and Republicans released the text of their “skinny” or “targeted” coronavirus relief bill. McConnell said a vote to proceed to the bill is expected Thursday....more

Goodwin

Year in Review: Top 5 Foreign Market Developments in 2018

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Here are our picks for the top-five most significant foreign biosimilar market developments in 2018: 1. Shake-up In Europe’s Adalimumab Market - As a result of litigation and resulting global settlements, several...more

Robins Kaplan LLP

Your Daily Dose of Financial News

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To no one’s surprise, the Fed followed through with its months of promises and raised its benchmark interest rate by 25 basis points yesterday. The FOMC also indicated that it’s planning to raise rates again in December....more

Goodwin

Lupin Announces Positive Results For Etanercept Biosimilar

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On February 7, 2018, Lupin announced positive results from a Phase III clinical trial for its etanercept biosimilar candidate, YB113. YB113 is being developed by YL Biologics, a joint venture of Lupin and Yoshido, a Japanese...more

Goodwin

First Etanercept Biosimilar to Receive Sales Approval in Japan

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Last Friday, Japanese company Mochida Pharmaceutical with Korean company LG Chem announced that it has received sales approval from the Japanese Ministry of Health, Labour and Welfare on its etanercept biosimilar (marketed by...more

Hogan Lovells

Dr. Frederick Ch’en discusses generic drugs and the changing pharmaceutical landscape in Asia

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Dr. Frederick Ch’en, an IP partner in Hogan Lovells’ Tokyo office, explains the political and demographic changes fueling changes in Japan and throughout Asia, and the practical impact on pharmaceutical companies doing...more

Holland & Knight LLP

Boletín Mensual de Comercio Internacional: Octubre Información con Ènfasis en la Regulación Comercial y de Arbitraje Internacional

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Durante el mes de Octubre destacan los siguientes temas: Comercio Internacional, Aduanero, Competencia, Normalización Telecom, Prácticas Desleales, Arbitraje ISDS....more

Goodwin

LG Life Sciences Begins Phase III Trials for Humira Biosimilar

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LG Life Sciences recently announced the start of phase III clinical trials for its Humira® (adalimumab) biosimilar in South Korea.  The clinical trials will test the effectiveness of the biosimilar on rheumatoid arthritis...more

Goodwin

Biocon Announces Insulin Glargine Biosimilar Has Met Key Phase III Milestones, Is On Track for US and EU Regulatory Filings

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Biocon recently announced that its global phase III clinical development program for biosimilar insulin glargine “has crossed key interim milestones,” putting Biocon “on track for regulatory filings in US and EU in FY 17.” ...more

K&L Gates LLP

Japan Enacts Regenerative Medicine Law and Revisions to Pharmaceutical Affairs Law

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On 20 November 2013, the Japanese Diet passed the Act regarding Ensuring of Safety of Regenerative Medicine (the "Regenerative Medicine Law") and the revisions to the Pharmaceutical Affairs Law (new PAL) as it applies to...more

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