Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
On March 10, 2024, Celltrion announced in a press release that it submitted an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P39 (omalizumab), a proposed interchangeable biosimilar of Genentech’s /...more
According to a January 2024 press release from Accord BioPharma, Inc. (“Accord”), the FDA accepted Accord’s abbreviated Biologics License Application (aBLA) for DMB-3115 (ustekinumab), a proposed biosimilar to Janssen...more
On November 30, 2023, Celltrion announced that it filed for an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P41 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab)...more
On June 29 and 30, 2023, respectively, Formycon AG (“Formycon”) and Celltrion Inc. (“Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates. Formycon and Celltrion are the second and...more
On April 5, 2023, Accord BioPharma announced that the FDA has accepted the Biologics License Application (BLA) for HLX02 referencing HERCEPTIN (trastuzumab) for adjuvant treatment of HER2-overexpressing breast cancer and...more
Innovent Biologics, Inc. announced the results of the Phase III ORIENT-31 study evaluating sintilimab in combination with BYVASDA (bevacizumab biosimilar) for the treatment of non-squamous non-small cell lung cancer. ...more
Under Section 262(l)(8)(A) of the BPCIA, a biosimilar maker must provide notice to the reference product sponsor 180 days before the date of first commercial marketing of the biosimilar. ...more
The Federal Circuit held that supplemental applications submitted to the Food and Drug Administration (FDA) to further support approval of a biosimilar product under Section 262(k) of the Biologics Price Competition and...more
On February 6, 2020, the U.S. Food and Drug Administration (“FDA”) issued a draft guidance (“Guidance”) that addresses the licensure of a biosimilar or biosimilar interchangeable product for fewer than all of the conditions...more
In December, in Amgen v. Hospira, 944 F.3d 1327 (Fed. Cir. 2019), a panel of the Federal Circuit issued the first decision applying the statutory Safe Harbor of 35 U.S.C. § 271(e)(1) to BPCIA patent litigation. ...more
It has been a busy week so far for biosimilar developers, with multiple collaboration and commercialization deals announced. First, on November 4, Henlius and Ascentage Pharma announced that they entered into a...more
On July 23, 2019, Amgen, maker of the cancer treatment drug Neupogen (filgrastim), filed patent infringement claims in the Southern District of California against Tanvex Biopharma over Tanvex’s proposed filgrastim biosimilar...more
Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’...more
A lot has happened since we last addressed new biosimilar developments in January 2018. In the intervening months, there have been many significant developments related to FDA’s implementation of an efficient regulatory...more
Since the passage of the Biologics Price Competition and Innovation Act (BPCIA), 2017 has been the most active year yet for drug manufacturers. Fish attorneys Tasha Francis, Jenny Shmuel, and Brianna Chamberlin addressed the...more
It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products....more
As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For...more
In an opinion issued on December 14, 2017, the United States Court of Appeals for the Federal Circuit held that the 2010 Biologics Price Competition and Innovation Act (“BPCIA”) preempts the use of state law to penalize...more
The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more
The Federal Circuit issued its opinion in the Amgen v. Hospira appeal (16-2179) on August 10, 2017, dismissing the appeal for lack of jurisdiction and denying Amgen’s petition for a writ of mandamus. The decision affirmed...more
In the third installment of the "Amgen v." trilogy of BPCIA Federal Circuit cases, the Court in Amgen Inc. v. Hospira, Inc. answered a question that had been lingering since the very first case -- can a reference product...more
While the Supreme Court held in Amgen v. Sandoz that biosimilar applicants cannot be forced with a federal injunction to provide a copy of their biosimilar application (aBLA) and manufacturing information to the reference...more
A theme emerging in biosimilar litigation is when –and how much—discovery is available to reference product sponsors. The Supreme Court in Amgen v. Sandoz grappled with this issue in the spring, as it decided whether...more
In a landmark ruling for the biotech and pharmaceutical industries, a unanimous Supreme Court decided Sandoz Inc. v. Amgen Inc., 582 U.S. ____, Nos. 15-1039, 15-1195 (June 12, 2017), its first biosimilar case governed by the...more
On June 12, 2017, the Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of...more