Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
4/18/2025
/ Amgen ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Hatch-Waxman ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sanofi
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
3/11/2025
/ Biosimilars ,
BPCIA ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Intellectual Property Litigation ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Requirements
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Welcome to Venable’s BiologicsHQ Monthly Injection – October 2024...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Welcome to Venable’s BiologicsHQ Monthly Injection – August 2024...more
8/27/2024
/ Biosimilars ,
Chevron Deference ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Inter Partes Review (IPR) Proceeding ,
Loper Bright Enterprises v Raimondo ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
Prescription Drugs ,
Purple Book
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
Welcome to Venable’s BiologicsHQ Monthly Injection – April 2024...more
5/1/2024
/ Biden Administration ,
Biologics ,
Biosimilars ,
Food and Drug Administration (FDA) ,
Interchangeability ,
Life Sciences ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...more
9/27/2023
/ Biologics ,
BPCIA ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Motion To Stay ,
Parallel Proceedings ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Webinars
The Inflation Reduction Act (IRA), signed into law on August 16, 2022, allows the federal government to negotiate prices for some high-cost drugs covered under Medicare. ...more
The Act’s Objectives -
USPTO data indicate that as many as 80% of instituted Patent Trial and Appeal Board (PTAB) proceedings that reach a final written decision (FWD) result in the invalidation of at least one challenged...more
At the beginning of July, seven additional Humira® (adalimumab) biosimilars, including one interchangeable, joined Amjevita™ (adalimumab-atto) in the US marketplace. Abrilada™ (adalimumab-afzb) is the only FDA-approved...more
As of July 24, 2023, the United States Patent and Trademark Office (USPTO) revised the interim Director Review process and replaced the Precedential Opinion Panel (POP) with the Appeals Review Panel process, which will review...more
On June 22, 2023, Senators Thom Tillis (R-N.C.) and Chris Coons (D-Del.) announced the reintroduction of legislation to reform the patent eligibility requirements under 35 U.S.C. § 101....more
Earlier today, the Supreme Court issued a unanimous decision in Amgen v. Sanofi, construing the statutory enablement requirement.
The case concerns antibodies that help reduce levels of LDL cholesterol....more
It has been 13 years since the Biologics Price Competition and Innovation Act (BPCIA) was enacted and biosimilars had a pathway to enter the U.S. market. While there have been challenges over this time, the U.S. biosimilar...more
On January 31, 2023, Amjevita™ (adalimumab-atto) entered the U.S. market as the first biosimilar of Humira® (adalimumab), after receiving approval in September 2016. Amjevita will be available in a low-concentration,...more
On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more
12/9/2022
/ Biosimilars ,
Clinical Trials ,
Drug Pricing ,
EU ,
European Medicines Agency (EMA) ,
Expedited Approval Process ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Interchangeability ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
UK
On September 19, 2022, the European Medicines Agency (EMA) and the Heads of Medicines’ Agencies (HMA) issued a joint statement explaining their scientific rationale for determining that biosimilars approved in the EU...more