Allison Inserro

Both the high-concentration and low-concentration versions of adalimumab-adaz (Hyrimoz) injection will launch in July, along with a wave of other biosimilars to Humira (reference adalimumab).

Under the Inflation Reduction Act, there is a 5-year temporary increase in the add-on payment for qualifying biosimilars whose average sales price (ASP) is not more than the price of the reference product.

Amneal said the product, to be sold under the name Alymsys, is the second of 3 US biosimilars the company expects to see approved this year.

A recent opinion column outlines some principles to consider when thinking about changing the current US system of financing drug innovation, especially potentially curative therapies.

Sandoz said it was reviewing all options, including a possible appeal to the Supreme Court. The case concerns Amgen's originator drug Enbrel and the biosimilar Erelzi.

Patients have problems getting timely authorizations for specialty meds and physicians face time burdens in getting them approved, a new report from CoverMyMeds says.

The UK results show how challenging switching to a biosimilar can be, according to patient groups.

The judge in the Humira case, while noting that the patents have made it nearly impossible for rivals to gain a foothold, said the suit did not constitute a valid antitrust claim.

Cancer treatments can lead to unpredictable adverse events, so a COVID-19–related measure allowing home infusion jeopardizes patient health and safety, according to the Community Oncology Alliance (COA).

Looking to March 23, the FDA released a question-and-answer guidance document for industry about the upcoming transition for how certain products will now be approved under a biological pathway, including exceptions to the transition and how companies will receive notifications about their applications.

The guidelines, based on clinical evidence, are a pathway to a shared decision-making process between patients and their physicians, said the American College of Rheumatology (ACR).

The FDA said it was no longer necessary to include the interpretation of the term “chemically synthesized polypeptide” as first proposed in December 2018.

Merck markets a biosimilar infliximab, Renflexis; a biosimilar trastuzumab, Ontruzant; and a biosimilar etanercept, Brenzys, in partnership with Samsung Bioepis.

Reference pricing may shift the mix of drugs dispensed from those offering the highest rebates to pharmacy benefit managers to those offering the lowest prices to employers and employees, according to a new study published Wednesday.

The FDA and the Federal Trade Commission (FTC) will work more closely to support a more competitive market for biosimilars and interchangeable products. In addition, the FDA published draft guidance for industry about how to advertise and promote biologic products truthfully and announced a public workshop.

In an effort to speed more generic drug approvals, the FDA said it is changing how it assigns priority review status to abbreviated new drug applications.

It is the only biosimilar candidate referencing Soliris to be granted investigational new drug approval in China.

Sorrento Therapeutics said this week it plans a 2020 Biologics License Application in the United States for a “biobetter” of infliximab.

Novo Nordisk said 3 measures to make insulin more affordable are now available, and it also announced that the FDA expanded use of its fast-acting mealtime insulin to children as young as 2.

Zirabev, which references Avastin, will be priced at a wholesale acquisition cost (WAC) of $61.34 per 10 mg, representing a 23% discount to the WAC of Avastin, Pfizer said.

With drug costs continuing to spiral and slower uptake in the United States compared to other parts of the world, it is perhaps natural for observers of biosimilars to ask questions, not only about well-known patent issues, but about deeper issues, such as the way biosimilars are developed, the meaning of interchangeability, and perhaps the very structure of the industry itself. Here’s a look at 5 hot topics from 2019.

Cases involving adalimumab featured in 2 of the 5 top legal stories in 2019 that dealt with various legal matters, including charges of patent thicketing.

During 2019, The Center for Biosimilars® provided interviews and discussions with key opinion leaders on our podcast to discuss various issues affecting biosimilars. From patent issues to the arrival of oncology biosimilars, here is a look at our top 5 podcast episodes from 2019.

Clinical developments, policy news, and pharmaceutical business updates ranked among our most popular conference stories of 2019.

AstraZeneca and Daiichi Sankyo said Monday they received FDA approval for their [fam-] trastuzumab deruxtecan-nxki, which will be marketed as Enhertu. [Fam-] trastuzumab deruxtecan is an antibody–drug conjugate (ADC) designed to delivery cytotoxic chemotherapy to cancer cells via a human epidermal receptor 2 (HER2) antibody attached to a novel topoisomerase I inhibitor payload and a tetrapeptide-based linker.

Amgen and Allergan submitted a Biologics License Application (BLA) to the FDA for ABP 798, a biosimilar rituximab referencing Rituxan.

A federal appeals court Wednesday struck down the individual mandate—the heart of the Affordable Care Act (ACA) that requires everyone to have health coverage—and sent the case back to the federal district court in Texas to determine whether other parts of the law are constitutional and can exist without the mandate.

Under the draft guidance for industry, the FDA is proposing how manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the US versions. Under this pathway, drug makers would use a new National Drug Code (NDC) and sell the products in the United States at a cheaper price—but different NDCs will not be available for use by biosimilar manufacturers.

Looking at products that entered the marketplace between 2015 and 2017, an FDA report finds that greater competition among generic drug makers is associated with lower prices.

Alberta became the most recent Canadian provincial government to mandate a nonmedical switch to biosimilars for certain patients on taxpayer-funded drug plans.