Business

During the Coherus Biosciences earnings call, the company announced that it was terminating its licensing agreement with Innovent Biologics for Byvasda, a bevacizumab biosimilar candidate referencing Avastin.

The United States is about to enter round 2 of biosimilar activity with a pipeline that expands biosimilars into new therapeutic areas, said Sonia Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars, Cardinal Health, during her presentation at Asembia’s Specialty Pharmacy Summit.

Although Roche’s earnings report for the first quarter of 2022 showed overall increases, products like Herceptin, Avastin, and Rituxan continue to lose revenue due to biosimilar competition.

Biosimilars provide significant savings and encourages competition in the biopharmaceutical marketplace but the United States needs to do more to empower uptake and address adoption barriers, according to Robert Popovian PharmD, MS.

Patients and other stakeholders received some biosimilar news, with a small recall for Mylan’s unbranded insulin glargine biosimilar and the completed full acquisition of Samsung Bioepis into Samsung Biologics.

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.

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, weighs in on the factors he thinks will most affect market share among adalimumab biosimilars when they enter the US market in 2023.

Republic of Korea-based Celltrion Healthcare launched its high-concentration adalimumab biosimilar in Canada and won several Brazilian tenders to supply its infliximab biosimilar.

Switzerland-based company Fresenius Kabi announced that its pegfilgrastim biosimilar received marketing authorization in Europe and that it has obtained a majority stake in biosimilar manufacturer mAbxience and acquired its subsidiary.

A series of initiatives to improve uptake of the biosimilars for 7 originator biologics resulted in significant savings for Providence St. Joseph Health.

Alvotech and Fuji Pharma signed a deal for a biosimilar in Japan; Signet partnered with Juno Pharmaceuticals to grow equity investment; and Sandoz expanded its ability to produce generic respiratory drugs by acquiring Coalesce.

OcyonBio signed a Good Manufacturing Practice (GMP) agreement for the manufacturing of biosimilars in Puerto Rico, while Evio Pharmacy Solutions implemented a strategy aimed at increasing biosimilar affordability.

Julie M. Reed, the new executive director of the Biosimilars Forum, shares how the Forum is preparing for the US market introduction of the first FDA-approved adalimumab biosimilars.

At a session at the Association of Community Cancer Centers’ 2022 Annual Meeting & Cancer Center Business Summit, panelists suggested that the quest for rebates by pharmacy benefit managers (PBMs) prevents uptake on some biosimilars—and could soon bleed over into biosimilar formulary placement.

AbbVie settles outstanding lawsuits, including its case related to the International Trade Commission (ITC), with Alvotech, giving Alvotech the green light to launch its high-concentration, citrate-free adalimumab biosimilar referencing Humira in July 2023, pending FDA approval.

Civica Rx will collaborate with companies to manufacture and distribute 3 insulin biosimilars and will offer them at an affordable price to uninsured and underinsured patients.

Shanghai Henlius Biotech announced a commercialization agreement with Getz Pharma Limited for an adalimumab biosimilar for various African and Asian countries.

Under a new agreement, Biocon Biologics will take over Viatris’ biosimilar business, according to statements made by the companies.

The FDA has accepted biologics license applications (BLAs) for interchangeability status from Alvotech and Pfizer regarding their respective adalimumab biosimilars referencing Humira.

A report from the National Alliance of Healthcare Purchaser Coalitions detailed the common concerns employers have regarding implementing biosimilars within their health care plans and outlined how they could take charge and make a difference.

There remains risk in the US market due to regulatory and legal hurdles—not to mention a combative political environment, according to executives who gathered last week during the “CEOs Unplugged” session at Access! 2022, held by the Association for Accessible Medicines (AAM) in Orlando.

Tuznue, which references Roche’s Herceptin, is currently under review for marketing authorization by the EU European Medicines Agency, Canada, and South Korea.

A report from AHIP found 3 drugs that have multiple biosimilars available can be delivered more affordably through specialty pharmacies.

Julie M. Reed, the new executive director of the Biosimilars Forum, talks about her experiences working with some of the biggest names in the biosimilars space and what she's taking with her into her new role.

Selexis and Generium launched an omalizumab biosimilar on the Russian market; Remsima sales hit a record high for Celltrion Healthcare; Xbrane Biopharma shares long-term results for its ranibizumab biosimilar.

The year 2021 proved to be big for biosimilars, with 4 approvals and increased competition, signaling that FDA is shifting some of their focus from the pandemic back to the growing industry.

Improving access and getting big legislative changes for biosimilars passed are just some of the many plans that Julie M. Reed, the new executive director of the Biosimilars Forum, has for the organization.

Biogen and Xbrane Biopharma signed a commercialization agreement for Xcimzane, a certolizumab pegol biosimilar referencing Cimzia for the treatment of rheumatoid arthritis, psoriasis, and other rheumatologic conditions.

Health Canada approves Ontruzant, the fifth Samsung Bioepis biosimilar to be approved for the Canadian market.

Xolair, the only currently approved product containing omalizumab, was first approved in 2003. AVT23 is an investigational compound and has not received regulatory approval in any country. Current sales of Xolair are estimated at $3.3 billion.