Gastroenterology

Alvotech, Advanz Pharma Extend Partnership for Biosimilars in Europe

June 3rd 2023

By Skylar Jeremias

Article

Alvotech and Advanz Pharma extend their partnership to commercialize 5 biosimilar candidates across Europe.

Mark Cuban’s Online Pharmacy Partners With Coherus Biosciences for Humira Biosimilar

June 1st 2023

By Skylar Jeremias

Article

The Mark Cuban Cost Plus Drug Company, an online pharmacy dedicated to increasing access to lower-cost prescriptions, is partnering with Coherus Biosciences to distribute Yusimry, a biosimilar referencing Humira. It’s the first time the pharmacy has added a biosimilar to its list of drugs.

Amgen’s Stelara Biosimilar Delayed Until 2025 After Settling With J&J

May 29th 2023

By Skylar Jeremias

Article

Amgen has settled with Johnson & Johnson (J&J) over the former’s ustekinumab biosimilar referencing Stelara, delaying the projected launch of the candidate from late 2023 to January 2025.

FDA Approves Celltrion’s Yuflyma, the Ninth Adalimumab Biosimilar

May 24th 2023

By Skylar Jeremias

Article

Celltrion Healthcare announced that the FDA has approved Yuflyma (adalimumab-aaty) as the ninth biosimilar referencing Humira (adalimumab).

Celltrion Launches Biobetter in Brazil, Shares Phase 3 Plan for MS Biosimilar

May 22nd 2023

By Skylar Jeremias

Article

As Celltrion Healthcare announces the launch of the biobetter version of Remsima (Remsima SC) in Brazil, the company shared the phase 3 plan for its ocrelizumab biosimilar to treat multiple sclerosis (MS).

Julie Reed: The Status Quo for Biosimilars Needs to Change to Maintain the Industry

May 11th 2023

By Skylar Jeremias

Article

The 2023 Asembia Specialty Pharmacy Summit featured Juliana (Julie) Reed, executive director of the Biosimilars Forum, who spoke on the challenges still facing the biosimilars industry and how they may impact the success of adalimumab biosimilars in the United States.

Samsung Bioepis Report Correlates Biosimilar Pricing Changes With Market Adoption

May 10th 2023

By Skylar Jeremias

Article

In the first edition of Samsung Bioepis’ Biosimilar Market Report, the company outlined the current state of the US biosimilars market and how increasing adoption has had an impact on pricing changes for biosimilars and their reference products.

Study on Nonmedical Switching for Adalimumab Biosimilars Warns About Nocebo Effect

April 27th 2023

By Skylar Jeremias

Article

Nonmedical switches from Humira (reference adalimumab) to a biosimilar or an adalimumab biosimilar to another biosimilar resulted in nocebo effect responses, suggesting that more communication between providers and patients is needed, according to a real-world analysis.

Multiple Infliximab Biosimilar Switches Appear Safe, Effective for Patients With IBD

April 20th 2023

By Justina Petrullo

Article

A retrospective study in Scotland found that multiple successive changes from originator infliximab to biosimilars seem to be safe and effective in patients with inflammatory bowel disease (IBD), irrespective of the number of switches.

FDA Issues Another CRL for Alvotech’s Adalimumab Biosimilar

April 14th 2023

By Skylar Jeremias

Article

In a complete response letter (CRL) for Alvotech, the FDA cited “deficiencies” in the company’s manufacturing facility during a reinspection, further delaying the approval for the ninth adalimumab biosimilar until potentially June 2023.