Policy

HHS Announces Plan to Allow Importation of Foreign Drugs, Potentially Including Insulin

July 31st 2019

By The Center for Biosimilars Staff

The first pathway for importation outlined in the plan would rely on a notice of proposed rulemaking to authorize importation of drugs from Canada. The second pathway would allow manufacturers to import versions of FDA-approved drugs that are sold in other countries.

Conservative Thinkers Share Their Views for Biosimilars in a Post-ACA, BPCIA Landscape

July 24th 2019

By Allison Inserro

Article

Earlier this month, a federal appeals court heard arguments in Texas v Azar. If the judge sides with the Republican point of view that the entire Affordable Care Act (ACA) is unconstitutional and invalidates the landmark law, the Biologics Price Competition and Innovation Act (BPCIA), the pathway for biosimilars included in the ACA, would have to start over from scratch. That shouldn’t be a problem, according to 2 conservative healthcare and pharmaceutical observers interviewed by The Center for Biosimilars®.

Court Calls Genentech's Actions In Trastuzumab Case "Contrary to the Spirit" of the BPCIA

July 24th 2019

By Kelly Davio

Article

Genentech had asked the court for a temporary restraining order and a preliminary injunction against Amgen in a Biologics Price Competition and Innovation Act (BPCIA) litigation related to patents covering Herceptin. The United States District Court for the District of Delaware denied Genentech’s motion, and the court has now made public a redacted version of the memorandum opinion in the matter.

Biosimilar Provisions Feature Heavily in Senate Finance Bill

July 24th 2019

By Kelly Davio

Article

The Senate Finance Committee has released its long-awaited chairman’s mark of the Prescription Drug Pricing Reduction Act of 2019. The bill, aimed at lowering the cost of drugs for American patients, contains a number of provisions that impact biosimilars.

Canadian Payer Applauds British Columbia for Switching Patients to Biosimilars

July 23rd 2019

By The Center for Biosimilars Staff

Article

This month, the president and chief executive officer of Green Shield Canada, the fourth-largest private payer in Canada, hailed British Columbia’s strategy as “forward-thinking” and “essential to maximizing opportunities in healthcare.”

Cruz Reintroduces Bill to Provide Reciprocal Access to Foreign Drugs

July 22nd 2019

By Allison Inserro

Article

Senator Ted Cruz, R-Texas, has reintroduced a bill he thinks will speed US approval of drugs, biologics, or devices approved in other countries.

Little-Known Provision of Senate Healthcare Bill Has Some Biosimilar Stakeholders Worried

July 19th 2019

By Kelly Davio

Article

When the Senate Committee on Health, Education, Labor, and Pensions released bipartisan legislation aimed at lowering the cost of healthcare in the United States in May, biosimilar stakeholders had some cause for optimism. However, one provision of the bill that has garnered significantly less attention from the broader healthcare community has raised concerns among many biologics stakeholders.

CBO Says Lower Health Care Costs Act Could Save $7.6 Billion by 2029

July 17th 2019

By Kelly Davio

Article

According to the Congressional Budget Office (CBO), enacting the bill would increase direct spending by about $18.7 billion and increase direct revenues by $26.2 billion, resulting in a net decrease in the deficit of $7.6 billion by 2029.

Part D Beneficiaries May Pay More for Some Generics, Biosimilars Than Brand-Name Drugs

July 17th 2019

By Jaime Rosenberg

Article

Medicare Part D enrollees may actually pay more for some generic drugs than they would for their brand-name counterparts because of the Part D benefit, according to findings of a new study appearing in Health Affairs.

House Democrats Ask US Trade Representative to Drop Biologics Language From USMCA

July 12th 2019

By Allison Inserro

Article

More than 100 House Democrats this week wrote to US Trade Representative Robert E. Lighthizer to ask him to drop language from the United States-Mexico-Canada Agreement (USMCA) trade agreement that would give 10 years of marketing exclusivity for biologic drugs.