Skylar Jeremias

A new bill (HR 8877) introduced to the House of Representatives is seeking to remove barriers that prevent the substitution of reference products with interchangeable biosimilars to support utilization of and access to lower-cost therapies.

Here are the top 5 biosimilar articles for the week of October 3, 2022.

Recently, the US got 2 new biosimilars on the market, a bevacizumab and an interchangeable ranibizumab; Amneal Pharmaceuticals filed for marketing authorization in Europe; and Sandoz released positive results for a denosumab candidate.

Two posters presented at the annual conference of the American Academy of Ophthalmology (AAO) demonstrated positive phase 3 results for proposed biosimilars that reference blockbuster drug, Eylea (aflibercept).

Ryan Haumschild, PharmD, MS, MBA, from Emory Healthcare and Winship Cancer Institute, explains how stakeholders may view the economic value of biosimilars differently based on their goals and his predictions for how biosimilar utilization will develop in the future.

On this episode of Not So Different, we take a look at some of the big stories regarding oncology biosimilars throughout the month of September, including 2 FDA approvals, and the withdrawal of a European application.

In addition to our month-long series preparing for the 2023 introduction of adalimumab biosimilars, September featured a number of updates for oncology biosimilars, including 2 FDA approvals and the withdrawal of a European application.

Vegzelma became the fourth biosimilar referencing Avastin (bevacizumab) to be approved for use in the United States for several types of cancer.

Here are the top 5 biosimilar articles for the week of September 26, 2022.

Health Canada approved Lupin Limited’s Rymti, the third etanercept biosimilar to be granted regulatory approval in the country. Meanwhile, Prestige Biopharma announced that it withdrew its European application for its trastuzumab biosimilar.

Part 5 available now! Paul Reider, MBA, chief commercial officer at Coherus Biosciences, chronicles why Coherus got an interchangeable designation for its ophthalmology biosimilar, how it plans to set its adalimumab biosimilar apart from the rest, and when the pegfilgrastim market could see a competitor for Neulasta Onpro.

The final part of this 4-part series assesses what payers should know about the US introduction of adalimumab biosimilars coming in 2023 as well as policy consideration they can implement to reap the benefits of biosimilar savings.

In this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, discussed current policy initiatives that could help biosimilar adoption and how the Inflation Reduction Act is expected to influence the adalimumab market.

Realigning definitions and policies across regulatory agencies and developing a better understanding of how different stakeholders approach biosimilars could help get more patients and providers on board with using biosimilars, according to panelists at the DIA Biosimilars Conference.

Here are the top 5 biosimilar articles for the week of September 19, 2022.

Panelists at the DIA Biosimilars Conference discussed how biosimilars can help address health care disparities and why patient notification for switching to biosimilars must be handled with caution.

As the United Kingdom adds another oncology biosimilar to its collection, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for another ranibizumab candidate.

A phase 1 study in Japan found similar pharmacokinetic (PK) and glucose pharmacodynamic (PD) parameters between the biosimilar SAR342434 (SAR-Lis, Sanofi) and the Japan-reference insulin lispro (Humalog) in healthy male participants.

Here are the top 5 biosimilar articles for the week of September 12, 2022.

The second part of this 4-part series looks at what patients and employers can expect when adalimumab biosimilars hit the market.

As Alvotech’s biosimilars are included in a commercialization deal in the Philippines, the company hits a setback in its quest for FDA approval of its adalimumab biosimilar; the FDA gives EpiVax a $2 million grant to run immunogenicity testing for biosimilars.

As part of a larger series preparing for the US market entrance of adalimumab biosimilars in 2023, Steven Lucio, PharmD, BCPS, senior principal of pharmacy solutions at Vizient, makes predictions for how the rollout of these biosimilars may play out and offers advice to stakeholders for how to maintain a robust market.

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.