biosimilars — Lanton Law Blog

CMS Makes An Impactful Change Regarding Biosimilars

Within its final calendar year 2025 Medicare Advantage and Part D final rule seen here, the Centers for Medicare and Medicaid Servces (CMS) is allowing Part D sponsors the ability to make midyear substitutions of biosimilars for their reference products on their formularies.

Congressional Bill Advocating for Biosimilars and Generics Introduced

U.S. Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT) have introduced the Affordable Prescriptions for Patients Act. The bill seen here seeks to lower drug prices by preventing bad actors’ anti-competitive use of patents to block generic and biosimilar competition from coming to market. The bill addresses two important issues such as product hopping and the patent dance.

FDA Approves First Interchangeable Biosimilar for Humira

According to the FDA’s press release, “The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases.”

FDA Approves First Interchangeable Biosimilar

Bipartisan Congressional Legislation Introduced Seeking Shared Savings Demo Project to Increase Biological/Biosimilar Medicare Access

U.S. Senators Cornyn (R-TX) and Bennet (D-CO) have introduced the Increasing Access to Biosimilars Act also known as S. 1427. The bill seeks to establish a demonstration project to increase access to biosimilar biological products under the Medicare program.

Two Biosimilar Bills Head to President Biden for Signature

Two Biosimilar Bills Head to President BIden for Signature

Biosimilar Legislation Passes Senate

S. 164 titled the Advancing Education on Biosimilars Act of 2021 sponsored by Senator Hassan (D-NH) has passed the Senate on March 3, 2021. The proposed bill seeks to educate health care providers and the public on biosimilar biological products.

Biosimilars Advocacy Group Outlines Congressional Wish List for 2021

The Association for Accessible Medicines sent letters to all members of Congress, which expressed what measures they would like them to take regarding access to biosimilars.

New Rule: Transition to BLA Pathway Is Complete

As of today, March 23, 2020, the life sciences industry completes “the transition.” New categories of biologics will now be licensed via the biologics approval pathway under the Biologics Price Competition and Innovation Act (BPCIA). This transition occurs 10 years after the 2009 enactment of the BPCIA.

Pending Antitrust Actions Could Change Biosimilar Dynamics

There are 3 major antitrust actions on the biosimilar scene still pending. These have a long way to go before any court resolution, unless the parties involved settle before then. One is a class-action lawsuit attacking the use of patent thickets and pay-for-delay tactics. The other is a claim alleging anticompetitive contract practices to retain market share for an originator product. Related to the latter, an investigation by the Federal Trade Commission (FTC) remains in progress.

Legislation to Play Significant Role in Drug Pricing Across Specialty Pharmacy

Jennifer Nessel of Pharmacy Times has featured Lanton Law in an article titled “Legislation to Play Significant Role in Drug Pricing Across Specialty Pharmacy.”

Lanton Law Presents at New York Bar Association's 2020 Annual Meeting

Lanton Law made a presentation on biosimilars at the New York Bar Association’s 2020 Annual Meeting in NYC.

healthcare, life sciences, biologics, BiosimilarsRon LantonFebruary 3, 2020biosimilars, biologics, New York Bar Association

Pharmacy Times Recaps Lanton Law's NASP Presentation on the FDA Biosimilars Action Plan

During the 2019 National Association of Specialty Pharmacy Annual Meeting and Expo, Ron Lanton III, Esq, reviewed the FDA Biosimilars Action Plan, its implications for the biosimilar marketplace, recent legislation set to influence the biosimilar pathway and drug accessibility, and the future of the biosimilar market.

Lanton Law Quoted in New Medscape Article On Biosimilar Insulin

A new US Food and Drug Administration (FDA) policy may help get novel biosimilar insulins to market more quickly, but it will be no guarantee that the products will be significantly less expensive than branded insulins, say analysts.

healthcare, CMS, life sciences, pharmaceuticals, pharmacy, home infusionRon LantonDecember 11, 2019insulin, FDA, Congress, insurance, biosimilars, biologics

Lanton Law's Webinar With WellSky Now Available

Our recently recorded webinar with WellSky is now available.

healthcare, home infusion, life sciences, pharmaceuticals, pharmacyRon LantonNovember 25, 2019biosimilars, home health, home infusion

The Specialty Pharmacist's Role in Educating Patients about Biosimilars and Biologics

Ron Lanton III, Esq. of Lanton Law discusses with Specialty Pharmacy Times the specialty pharmacist's role in educating patients about biosimilars and biologics

The Specialty Pharmacist's Role in Educating Patients about Biosimilars and Biologics

Ron Lanton III, Esq., discusses the specialty pharmacist's role in educating patients about biosimilars and biologics.

healthcare, life sciences, pharmacy, pharmaceuticalsRon LantonNovember 3, 2019biologics, biosimilars, pharmacy, specialty pharmacy

The Challenges to Launching Biosimilars

Check out Ron Lanton’s interview with Specialty Pharmacy Times on “The Challenges to Launching Biosimilars” https://www.pharmacytimes.com/news/challenges-to-launching-biosimilars

healthcare, life sciences, pharmacy, home infusionRon LantonOctober 24, 2019biosimilars, biologics

How Will the United States–Mexico–Canada Agreement Affect Biosimilars?

For years we have witnessed the fierce debate over whether the North American Free Trade Agreement (NAFTA) is serving the best interests of the United States. In following up on a 2016 campaign promise to renegotiate NAFTA, the new NAFTA, called the United States–Mexico–Canada Agreement (USMCA), is currently being debated by Congress, and there are concerns as to whether the agreement will be ratified.

healthcare, life sciences, tradeRon LantonOctober 18, 2019Congress, biologics, biosimilars, USMCA