Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser
Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Podcast: Non-binding Guidance: Expedited Review Programs for Drugs and Biologics
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
A changing competitive landscape: the role of the ITC in the biosimilars space
On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...more
On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA)...more
The Inflation Reduction Act’s (“IRA”) drug price negotiation provisions have captured the pharmaceutical and biotech industry’s attention. In part, the IRA allows the Centers for Medicare & Medicaid Services (“CMS”) to...more
Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more
Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Mike Druckman, Ernesto Algaba, Mandi Jacobson, Lu Zhou, Mikael Salmela, Charlotte Damiano, and Lowell Zeta, along...more
Antibodies are part of the body’s adaptive immune response to defend itself against toxins and pathogens, such as bacteria and viruses. When the body identifies a foreign entity, it mounts a cascading response that culminates...more
During the first quarter of 2021, multiple companies launched adalimumab biosimilars as a growing number of biosimilar players marketed their versions of the world’s most profitable drug, Humira®, which had sales of about $20...more
The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe. As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or...more
As described below, Adocia, Cue Biopharma, and Eucure Biopharma each recently announced clinical updates with regards to their biologic product candidates or combination therapies. Adocia, a clinical-stage biotechnology...more
The world-wide market share of biologic drugs is advancing at a staggering pace, with some estimates ranging from $ 300 billion to $452 billion in revenue within the next five years.The treatment costs for patients...more
On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more
The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more
Buried in a 2020 spending bill passed in December 2019 is a provision that amends the definition of “Biological Product” in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and thereby expands the products...more
2019 marks the 9th anniversary of the Biologics Price Competition and Innovation Act (BPCIA). ACI has been with you from the introduction of the first House and Senate bills through to the actual signing of the law. As we...more
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
U.S.-based life sciences companies considering transactions in Europe may easily become overwhelmed with the complexity of Europe’s various jurisdictions. In this series, members of our European Life Sciences Transactions...more
On August 5th, the U.S. Food and Drug Administration issued a "Guidance for Industry" entitled "Reference Product Exclusivity for Biological Products file under Section 351(a) of the PHS Act." Before setting forth the first...more
Last month, in a letter to the U.S. Trade Representative, Ambassador Michael Froman, Biotechnology Industry Organization (BIO) President and CEO James Greenwood expressed support for the efforts of the Obama Administration to...more