Skylar Jeremias

A phase 1 study of an enoxaparin sodium biosimilar Cloti-Xa established similar pharmacodynamics and pharmacokinetic profiles with the reference product (Clexane, Lovenox) in healthy participants.

Here are the top 5 biosimilar articles for the week of September 5, 2022.

In a recent paper, Sarfaraz K. Niazi, PhD, argues that getting rid of clinical efficacy testing for biosimilars could realign testing ethics with current guidelines, save companies money on development, and improve data sensitivity.

Celltrion Healthcare released positive data for an ustekinumab biosimilar, and Samsung Bioepis announced long-term safety and efficacy results for its adalimumab biosimilar.

Fresenius Kabi announced the FDA approval of its pegfilgrastim biosimilar referencing Neulasta, making it the sixth pegfilgrastim biosimilar to be approved in the United States.

In the first article of a 4-part series, The Center for Biosimilars® offers specifics for each of the adalimumab biosimilar products coming in 2023 and explains why the experience in Europe may differ from what’s coming in the United States.

Thanks to the success of its adalimumab biosimilar in Canadian and European markets, Alvotech’s revenues reached over $40 million during the first 6 months of 2022, nearly 20 times more than its revenue from the same period in 2021.

On this episode of Not So Different, we look back at some of the biggest regulatory events to happen in the biosimilar space during August, including 2 European approvals, 2 US approvals, and the advancement of the Inflation Reduction Act of 2022.

Here are the top 5 biosimilar articles for the week of August 29, 2022.

August brought with it 2 regulatory approvals for ophthalmology biosimilars, an FDA approval for a high-concentration adalimumab biosimilar, and the passage and signing of the Inflation Reduction Act of 2022.

The European Commission granted marketing authorization to Teva’s ranibizumab biosimilar (Ranivisio), the second ophthalmology biosimilar and the second biosimilar to reference Lucentis to be approved in the European Union.

Here are the top 5 biosimilar articles for the week of August 22, 2022.

Vizient’s 2022 Biosimilar Survey found that health care organizations consider interchangeable designations to be very important in prescription decision-making, signaling the interchangeability could play a big role in the adoption of adalimumab biosimilars.

Cheryl Vaughn, vice president of clinical services at McKesson, discussed how McKesson's Intrafusion service helps manage infusion sites and aids in the administration of complex biologic drugs, including biosimilars.

The European Commission (EC) authorized Celltrion Healthcare’s bevacizumab biosimilar referencing Avastin for marketing across the European Union, making it the seventh bevacizumab biosimilar to be approved in the region.

Here are the top 5 biosimilar articles for the week of August 15, 2022.

The FDA approval of Samsung Bioepis’ high-concentration, citrate-free formulation of Hadlima, a biosimilar referencing Humira (adalimumab), is the first high-concentration adalimumab biosimilar to be approved in the United States.

Celltrion Healthcare set its sights on obtaining an interchangeability designation for its adalimumab biosimilar, and Formycon released positive findings from a phase 3 trial involving its ustekinumab biosimilar.

Researchers found that the percentage of biosimilar uptake is a better predictor of whether prices of biologics will significantly decrease, refuting the argument that more biosimilars for a single reference product will have the biggest impact.

Here are the top 5 biosimilar articles for the week of August 8, 2022.

A systematic review found that patients who were switched from one biosimilar to another did not experience a change in clinical outcomes or an increase in adverse events.

While efforts to cap monthly insulin costs for Medicare patients at $35 survived a budget reconciliation bill in the Senate, Republicans blocked the measure from extending to the private sector.

On this episode of Not So Different, we recap some of the biggest biosimilars news that happened over the past month, including updates on clinical trials for oncology biosimilars as well as a survey on whether patients were given adequate information prior to switching a biosimilar.

Here are the top 5 biosimilar articles for the week of August 1, 2022.

Vizient’s Pharmacy Market Outlook report offers predictions on how the emergence of adalimumab biosimilars in 2023 will affect the biosimilar industry and what actions should be taken in advance to ensure biosimilar adoption.

Trials for denosumab biosimilars are ramping up and researchers are concerned whether patients with cancer switching to biosimilars have been adequately informed beforehand.

Jim Carey, head of US policy and government relations at Organon, a spinoff company from Merck, breaks down strategies to push forward biosimilar legislation, the anticipation for adalimumab biosimilars, and more in this multi-part interview.

Biocon’s revenues for the quarter were up by 23% from last year, thanks to the success the company has had with biosimilars, of which revenues increased by 29%, and generic drugs, which had an increased revenue of 19%.

Prestige Biopharma and Intas Pharmaceuticals join forces to partner on a bevacizumab biosimilar for multiple countries, and Hikma Pharmaceuticals makes a deal with Celltrion Healthcare for the commercialization of an adalimumab biosimilar.

Sandoz’ applications for its Tysabri biosimilar (natalizumab) and its high-concentration version of its Humira biosimilar (adalimumab) were accepted for review by the FDA and the European Medicines Agency.