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 August 12, 2025, Lupin Limited (“Lupin”) announced that it has partnered with Sandoz Group AG (“Sandoz”) to market and commercialize Lupin’s biosimilar ranibizumab across multiple regions. Ranibizumab is a recombinant...more
On April 7, 2025, Teva Pharmaceuticals and Samsung Bioepis Co., Ltd. announced the U.S. launch of EPYSQLI® (eculizumab-aagh), a biosimilar referencing Alexion Pharmaceuticals’ SOLIRIS®....more
On January 27, 2025, Alvotech and Teva announced FDA acceptance of the Biologics License Application (BLA) for AVT05, a proposed biosimilar to SIMPONI and SIMPONI ARIA. This marks the first U.S. BLA acceptance for a...more
On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia....more
This Monday, Bio-Thera Solutions announced that it would be expanding its Latin American biosimilar marketing partnership with SteinCares....more
On October 3, 2024, Teva Pharmaceuticals and mAbxience, a Fresenius Kabi majority-owned group, announced a new global licensing agreement for the development of an anti PD-1 oncology biosimilar candidate, further...more
Alvotech and Teva announced an expansion of their existing strategic partnership agreement relating to biosimilars products in the U.S. According to the announcement, the existing agreement includes AVT02, an...more
Advanz Pharma (“Advanz”) and Alvotech announced that they entered an exclusive partnership agreement regarding supply and commercialization of five biosimilars in Europe, with Alvotech responsible for the development...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
This week, three development programs announced updates to their ranibizumab biosimilars. Ranibizumab is the active ingredient in Genentech’s LUCENTIS, which is indicated for retinal vascular disorders, including neovascular...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
Alvotech and Cipla Medpro, a wholly owned subsidiary of Cipla Limited, recently announced an exclusive partnership “to bring key biosimilars to patients in markets such as South Africa.” The biosimilars portfolio will include...more
Alvotech and DKSH recently announced an expansion of their strategic partnership to commercialize six new biosimilar candidates for the Asian markets. The press release does not name the biosimilar candidates, but states that...more
Today Alvotech and Teva announced that they have entered into an exclusive strategic partnership for the commercialization of five biosimilar candidates in the U.S. Under the partnership agreement, Alvotech will be...more
Below are some recent developments in the biosimilar industry from around the globe: On January 14, 2020, Alvotech announced that it entered into a partnership with Canada-based JAMP Pharma for the supply and...more
On December 14, 2018, Prestige Biopharma (“Prestige”) announced a partnership with Cipla Ltd. (“Cipla”) for Prestige’s HD201, a proposed trastuzumab biosimilar of Roche’s Herceptin®. Prestige’s HD201 is in Phase-3 clinical...more
Lupin Ltd. and Mylan N.V. both issued press releases today announcing a collaboration to commercialize a biosimilar to Amgen’s Enbrel® (etanercept). Mylan will commercialize Lupin’s proposed etanercept biosimilar in Europe,...more
Last week, Fujifilm Kyowa Kirin Biologics (FKB) and Mylan announced that they will partner with one another to commercialize in Europe FKB327, a biosimilar of adalimumab developed by FKB. As we previously reported, the...more
On November 14, 2017, Theradiag, a French company specializing in in vitro diagnostics, announced that it had entered into a partnership agreement with Biogen to provide LISA TRACKER kits for monitoring Flixabi®, Biogen’s...more
On October 19, 2017, Abzena plc and UGA Biopharma Gmbh announced that their partnership completed development of an NS0 (murine myeloma) manufacturing cell line. This cell line expresses a biosimilar of a therapeutic antibody...more
Yesterday, two groups announced the submission of applications seeking FDA approval of biosimilars of Herceptin® (trastuzumab), which is indicated for the treatment of HER2-positive early breast cancer, adjuvant breast...more
Celltrion and Teva announced today that the FDA has accepted for standard review their BLA for CT-P10 and that regulatory action is expected in the first quarter of 2018. CT-P10 is a proposed biosimilar to Rituxan®...more
Teva Pharmaceutical Industries Ltd., Celltrion, Inc. and Celltrion Healthcare announced that the companies have entered into an exclusive partnership to commercialize two of Celltrion’s biosimilar candidates: CT-P10, a...more