Policy

Senate Bill Seeks to Give FTC Authority to Fight Patent Thickets, Product Hopping

May 15th 2019

By The Center for Biosimilars Staff

The bill codifies definitions of product hopping and patent thicketing within the Federal Trade Commission (FTC) statute, allowing the FTC to challenge these practices as anticompetitive and to enable the FTC to bring antitrust suits against drug companies.

Inside the UK Switch to Biosimilar Adalimumab

May 15th 2019

By Kelly Davio

During the Biosimilars Commercialisation Summit, held May 14-15, 2019, in Amsterdam, the Netherlands, a specialist pharmacist for a large National Health Service healthcare trust explained how the transition to biosimilars worked at a practical level in the UK home care system, and shared lessons learned from the experience.

The Need for and Realities of Biosimilars in Generating Health System Savings

May 15th 2019

By Kelly Davio

During the Biosimilars Commercialisation Summit 2019, held May 14-15 in Amsterdam, the Netherlands, among the key topics of discussion was the sustainability of the world’s healthcare systems and the need to create savings in order to continue to advance the treatment of cancer and chronic diseases.

FDA Hears From Stakeholders About Insulin Transition to Biologic Pathway in 2020

May 14th 2019

By The Center for Biosimilars Staff

Set against a backdrop of rising concern about the cost of insulin, the FDA held a hearing about biosimilar insulins Monday, 10 months before the products transition in March 2020 from the Food Drug and Cosmetic Act to biologics under the Public Health Service Act.

HTA Frameworks for RA Therapies Need Improvement, Researchers Say

May 13th 2019

By Kelly Davio

Cost-effectiveness models for the treatment of rheumatoid arthritis (RA) first emerged in the early 2000s when highly effective but also high-cost biologic therapies began to reach patients. However, these health technology assessment (HTA) models need improvement, a recent paper says.

Australia's GBMA Launches Hub for Biosimilar Education

May 13th 2019

By The Center for Biosimilars Staff

In 2018, The Generic Biosimilar Medicines Association (GBMA) was awarded the Biosimilar Education Grant by the Australian government to develop an educational program for Australian stakeholders with the aim of increasing confidence in biosimilars that are listed on the nation’s public drug benefit plan. Now, the GBMA has launched an educational hub.

CBO Says Bill to Curb Pay-for-Delay Would Cut the Deficit by $613 Million Over 10 Years

May 10th 2019

By Kelly Davio

The bill seeks to prohibit brand-name drug makers from delaying the entry of generics or biosimilars by compensating competitors to keep their products off the market for a period of time in so-called pay-for-delay arrangements.

The Top 5 Biosimilars Articles for the Week of May 6

May 10th 2019

The Center for Biosimilars® recaps the top news for the week of May 6, 2019.

Congress Votes on Amending Orange and Purple Books in Effort to Encourage Generics and Biosimilars

May 8th 2019

By Kelly Davio

The House of Representatives has passed a pair of bills that make changes to the FDA’s Orange Book and Purple Book, which provide information on generic drugs and biosimilars, respectively.

HHS Sets Details of Finalized Rule Requiring List Prices to Be Disclosed in DTC Ads

May 8th 2019

By Allison Inserro

In an effort to improve price transparency, the Trump administration on Wednesday announced a final rule requiring drug manufacturers to disclose their list prices for pharmaceutical products or biologics in television ads for drugs covered by Medicare or Medicaid if the wholesale acquisition cost is $35 or more for a month’s supply. Affected drugs include adalimumab (Humira), with its wholesale acquisition cost (WAC) of $5174 per month, and etanercept (Enbrel), with its WAC of $5174 per month.