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The current market value of the branded sales for these biosimilars is estimated to exceed $2 billion annually, the companies said.

An accompanying editorial describes the current regulatory process as “a thicket of special programs, flexible review criteria, and generous incentives,” and suggests starting points for reforms, including improving access to biosimilars.

In the United States, recent analyses show that biosimilars achieved just 9%, or $91 million, of the $1 billion in cost savings that the Congressional Budget Office projected 10 years ago.

The final report includes voting results from a December 2019 meeting of one of ICER’s independent evidence appraisal panels, the California Technology Assessment Forum (CTAF), plus policy recommendations from an expert roundtable.

The Center for Biosimilars® recaps the top stories for the week of January 6.

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

It is the first adalimumab biosimilar approved by the China National Medical Products Administration.

The study follows others that have found that SB4 works well for the majority of patients who switched from the originator etanercept, Enbrel.

Two studies recently reported on Hulio, the adalimumab biosimilar marketed and developed by Mylan and its partner Fujifilm Kyowa Kirin Biologics.

The law made California the first state to bar pay-for-delay pharmaceutical agreements by making them presumptively anticompetitive if the nonreference drug maker receives anything of value from the other company.

The Innovation and Value Initiative (IVI) has updated its existing prototype economic model examining value among rheumatoid arthritis (RA) therapies to include biosimilars.

In 2019 the FDA approved 48 novel drugs and 10 biosimilars, according to the Center for Drug Evaluation and Research (CDER).

Just 6% of the Asian doctors said they felt confident using biosimilars in clinical practice. A survey of European doctors found a similar confidence level in 2013, but that level had climbed to 28.8% by 2015.

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.

Indian private equity firm True North could soon hold a 2.44% minority stake in Biocon Biologics India Ltd, a subsidiary of Biocon Ltd, thanks to a $100-million investment. The influx of cash values Biocon Biologics at close to $3 billion. The investment is pending regulatory approval.

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.

In late December, Spectrum Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application for eflapegrastim, a novel drug that could, if approved, compete with existing granulocyte colony-stimulating factor (G-CSF) therapies and their biosimilars.

The findings indicate that interventions that leverage physician relationships may assist with increasing uptake of new, high-value cancer treatments in place of low-value therapies.

Using the biosimilar resulted in a significantly lower drug acquisition cost, at $533.40 in the biosimilar group versus $1261.90 in the reference group.

The Center for Biosimilars® recaps the top stories for the week of December 30, 2019.

Last month, Gilead Sciences submitted a New Drug Application (NDA) to the FDA for filgotinib under the priority review process. Filgotinib is a Janus kinase (JAK) inhibitor aimed at moderate-to-severe rheumatoid arthritis (RA).

The Inflammatory Bowel Disease Net, an official working group of the Swiss Society of Gastroenterology, has issued a new position statement on the use of biosimilars in treating inflammatory bowel disease (IBD).

China-based Clover Biopharmaceuticals announced this week that it has dosed the first patient in a phase 3 clinical study of SCB-808, a proposed etanercept biosimilar referencing Enbrel.

While anti–tumor necrosis factor (anti-TNF) drugs are effective at treating a range of inflammatory diseases, some limited data suggest that they may, paradoxically, result in a higher risk of developing other de novo inflammatory conditions.

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.

When it comes to US biosimilars, 2019 was the busiest year yet for regulatory activity, with a bevy of new approvals and the publication of long-awaited guidance documents.

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.

Intravitreal injection with anti–vascular endothelial growth factor (anti-VEGF) drugs has represented a major step forward for patients with retinal diseases, and the upcoming biosimilars market for these drugs—including aflibercept and ranibizumab, as well as off-label bevacizumab—is beginning to take shape. However, there have been some lingering concerns about the safety of these drugs, as increased mortality has been reported after anti-VEGF treatment in the general population.

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.