Yukon Becomes Tenth Canadian Jurisdiction to Add Biosimilars Switching Policy
March 30th 2023Yukon, 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.
The Increasing Access to Biosimilars Act of 2023 Introduced to Congress
March 29th 2023The Increasing Access to Biosimilars Act of 2023 (HR 1352), a bill that would direct HHS to establish a demonstration project within Medicare that would establish a shared savings model for biosimilars, was introduced to the House of Representatives.
Favorable Equivalency Studies of Candidate Biosimilar AVT04 and Reference Ustekinumab
March 27th 2023Posters 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).
A Long Time Coming: Dr Sophia Humphreys Details What’s Coming Down the Biosimilar Pipeline
March 23rd 2023In the wake of adalimumab biosimilars hitting the US market, Sophia Z. Humphreys, PharmD, MHA, BCBBS, of Sutter Health, hyped up the current biosimilar market trends and the other products coming down the pipeline during her talk at the Festival of Biologics.
Published Data Coupled With Real-world Evidence Show Safety of Biosimilar-to-Biosimilar Switching
March 22nd 2023At the Festival of Biologics, Hillel Cohen, the executive director of scientific affairs at Sandoz, shared the current body of literature on biosimilar-to-biosimilar switching, saying that although there isn’t much published data, the vast real-world experience demonstrates the safety of this type of medication switch.
Uptake Barriers Will Deter Future Competitors From Investing in Biosimilars, Julie Reed Warns
March 21st 2023At the Festival of Biologics, Juliana (Julie) Reed, executive director of the Biosimilars Forum, warned that without changes to encourage biosimilar uptake, companies will begin to ask the big question: Are biosimilars worth investing in?
How Community Oncologists Can Break Down Biosimilar Adoption Barriers
March 19th 2023On this episode of Not So Different, Mark Guyot, senior director of unity provider engagement at McKesson, gives an overview of McKesson’s real-world analysis of community oncology practices and their use of biosimilars and offers advice on overcoming adoption barriers and expanding education efforts.
Retrospective Study Supports Safety of Anti-TNF Biosimilars During Pregnancy
March 18th 2023More 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 2023In 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.
Biorationality: A Dr Sarfaraz Niazi Column—A New Perspective on Biosimilars' Role Within Big Pharma
March 13th 2023Sarfaraz K. Niazi, PhD, explained why Indian manufacturers aren’t bringing biosimilars to the United States and how FDA policies and procedures discourage global companies from pursuing US market entry.
IQVIA's Michael Kleinrock Shares Why Smaller Manufacturers Are Investing in Biosimilar Development
March 12th 2023Better familiarity with biosimilars is enabling government agencies to reevaluate their approval requirements and encouraging smaller manufacturers to invest in biosimilar development, said Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science.
Eye on Pharma: FDA, EMA Accept Biosimilar Applications; Biosimilar Trials Begin
March 9th 2023The 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.
White Paper Argues Increased Competition Will Improve Biosimilar Uptake, Savings
March 8th 2023A white paper touting biosimilar successes in the United States reasoned that increased market competition will help improve utilization rates, generate substantial savings, and encourage payers to cover biosimilars.