Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe. ...more
According to news reports, Celltrion recently launched VEGZELMA (bevacizumab) in Japan. In September 2022, the drug received sales approval from the Japanese Ministry of Health, Labor and Welfare for the treatment of...more
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
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
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
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
As we reported last month, YL Biologics (a joint venture between Lupin’s subsidiary Kyowa and Yoshindo) recently submitted a New Drug Application (NDA) for Marketing Authorization of Japan’s Pharmaceuticals and Medical...more
Several biopharmaceutical developers recently announced significant regulatory submission activity in connection with biosimilar products in their pipelines. In addition to yesterday’s news about the U.S. FDA’s approval of...more
Last week, Japan-based Nichi-Iko Pharmaceutical Co. announced the completion of a biologics production facility in Osong, South Korea by its Korean affiliate Aprogen Biologics “[t]o provide a stable supply of premium quality...more
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
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
Please see full chart below for approved biosimilar products around the world. ...more
Biosimilar uptake in Japan has been a bit mixed, but according to experts the volume shares of biosimilars suggests it could be a key market in years to come. The Pharmaceuticals and Medical Devices Agency (PMDA), which is...more
On April 27, 2017, The Korea Herald and The Investor reported that Celltrion and Nippon Kayaku entered into an agreement under which Nippon Kayaku will sell Truxima, Celltrion’s biosimilar of Rituxan, in Japan. According to...more
Celltrion announced last week that it has filed for marketing approval of Herzuma (trastuzumab) with Japan’s Ministry of Health, Labor and Welfare. Herzuma is indicated for the treatment of breast and gastric cancers...more
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
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