September 20th 2023
In the final part of a 3-part series, Sarfaraz K. Niazi, PhD, gives his take on the FDA's recent workshop dedicated to streamlining biosimilar development and his opinion on what the industry can learn from the webinar presenters.
September 7th 2023
Stelara and Enbrel Chosen for IRA Price Negotiation
August 29th 2023Stelara (ustekinumab) and Enbrel (etanercept), 2 originator medications that will face biosimilar competition within the next decade, were among the 10 preliminary drugs chosen for Medicare price negotiation under the Inflation Reduction Act (IRA).
Contributor: The Promise of RA Biosimilars Could Be Realized, but Greater Adoption Rates Are Needed
August 14th 2023Robert Zutaut, RPh, a clinical specialist from McKesson Provider Solutions, quantifies the major barriers to adoption for biosimilars used to treat rheumatoid arthritis (RA) and some major considerations for health systems looking to address them.
Spanish Psoriasis Working Group Revises Guidelines for Biosimilars in Psoriasis
August 10th 2023The Spanish Psoriasis Working Group updated its position on the use of biosimilar medicines in patients with moderate to severe psoriasis, including its views on biosimilars as first-line treatment and nonmedical switching.
Authors Suggest Major Policy Shifts to Boost Biosimilar Development, Accessibility
August 9th 2023Streamlining biosimilar development would permit biosimilar development of more and a wider variety of biological drugs, fast-tracking biosimilar development without impacting patient safety or effectiveness, according to an opinion piece.
AAM White Paper Breaks Down Drug Shortage Crisis: Causes and Solutions
July 25th 2023The Association for Accessible Medicines (AAM) published a white paper on the impact that ongoing drug shortages have had on the generic and biosimilar industries as well as possible solutions stakeholders can put into action.
Senator Reintroduces Biosimilar Red Tape Elimination Act
July 14th 2023Senator Mike Lee (R, Utah) reintroduced the Biosimilar Red Tape Elimination Act to Congress. The bill aims to get rid of switching study requirements for companies looking to obtain an interchangeability designation for a biosimilar.
Mark Cuban’s Online Pharmacy Partners With Coherus Biosciences for Humira Biosimilar
June 1st 2023The 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.
Biosimilar Acceptance Takes Time but Policy Intervention Is Needed, Panelists Say
May 25th 2023A group of panelists at Asembia 2023 shared the bigger role that pharmacists, payers, and providers can play in growing biosimilar acceptance and championing policy changes that boost biosimilar utilization.
Biorationality: Advice for the FDA, Biosimilar Developers on Reducing the Cost of Clinical Testing
May 15th 2023Although the FDA has consistently edited its testing guidelines for biosimilar developers over the years, clinical testing is still very expensive and time-consuming. Sarfaraz K. Niazi, PhD, offers the FDA and companies a plan of action for reducing clinical testing expenses for biosimilar products.
Julie Reed: The Status Quo for Biosimilars Needs to Change to Maintain the Industry
May 11th 2023The 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.
Biosimilars Check In: Vegzelma Launch, BLA Acceptances, China Approval
April 26th 2023Over the past week, Vegzelma, a bevacizumab biosimilar, launched in the United States; 2 biologics license applications (BLAs) for biosimilars were accepted for review by the FDA; and China’s regulatory agency approved a denosumab biosimilar.
Study Reveals Factors That Dissuade Commercial Plans From Covering Biosimilars
April 19th 2023A study assessing factors that may determine a commercial health plan’s likelihood of covering a biosimilar found that biosimilars that are cancer therapies, used to treat children, indicated for highly prevalent conditions, or only competing against the originator were more likely to have coverage restrictions.
FDA Issues Another CRL for Alvotech’s Adalimumab Biosimilar
April 14th 2023In 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.
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.
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?