Dermatology

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.

Spherix Global Insights: Despite High Awareness, Provider Comfort With Adalimumab Biosimilars Is Low

April 3rd 2023

By Skylar Jeremias

Article

Although rheumatologists, dermatologists, and gastroenterologists rated their awareness of adalimumab biosimilars as high, a significant proportion of each group reported that they were not confident prescribing a biosimilar over the originator.

Yukon Becomes Tenth Canadian Jurisdiction to Add Biosimilars Switching Policy

March 30th 2023

By Skylar Jeremias

Article

Yukon, 1 of 3 Canadian territories, announced that it will implement a biosimilars switching policy, following Newfoundland and Labrador’s announcement to move forward with a similar policy earlier this week.

Canadian Province Newfoundland and Labrador Adds Biosimilar Switching Policy

March 28th 2023

By Skylar Jeremias

Article

Newfoundland and Labrador is the latest Canadian province to implement a biosimilar switching policy, following in the footsteps of Ontario and 7 other jurisdictions.

Favorable Equivalency Studies of Candidate Biosimilar AVT04 and Reference Ustekinumab

March 27th 2023

By Justina Petrullo

Article

Posters presented by Alvotech at 2023 American Academy of Dermatology (AAD) annual meeting showcased proven bioequivalence and therapeutic equivalence candidate biosimilar AVT04 and reference ustekinumab (Stelara).

Samsung Bioepis’ Stelara Biosimilar Proves Successful in Phase 1 Study

March 20th 2023

By Skylar Jeremias

Article

At the American Academy of Dermatology annual meeting, Samsung Bioepis shared positive results from a phase 1 study comparing its ustekinumab biosimilars (SB17) with the reference product (Stelara).

Retrospective Study Supports Safety of Anti-TNF Biosimilars During Pregnancy

March 18th 2023

By Deana Ferreri, PhD

Article

More and more women are becoming pregnant while on anti–tumor necrosis factor (TNF) biosimilars used to treat inflammatory disorders. However, there is “little data” on the safety and effectiveness of biosimilars in pregnancy, according to authors of a recent retrospective study.

CVS Predicts Interchangeability Won’t Drive Adalimumab Biosimilar Adoption

March 15th 2023

By Skylar Jeremias

Article

In a report from CVS Health, interchangeability will not be a primary factor in driving the adoption of adalimumab biosimilars referencing Humira, contradicting predictions from other sources that believe the designation will impact prescribing habits.

Eye on Pharma: FDA, EMA Accept Biosimilar Applications; Biosimilar Trials Begin

March 9th 2023

By Skylar Jeremias

Article

The FDA and the European Medicines Agency (EMA) accepted applications for a trastuzumab biosimilar and an ustekinumab biosimilar, respectively, and Altos Biologics completed patient enrollment for a phase 3 trial assessing an aflibercept biosimilar.

Report: Over 60% of Providers Plan to Only Prescribe Interchangeable Adalimumab Biosimilars

February 23rd 2023

By Skylar Jeremias

Article

In Cardinal Health’s 2023 Biosimilars Report, more than 60% of surveyed providers said they would only want to prescribe adalimumab biosimilars with interchangeability designations, suggesting the label may have a greater impact on uptake than originally expected.