Skylar Jeremias

The FDA has issued an update to its guidance on requiring switching study data for biosimilars to be granted interchangeability, citing new science that shows these studies aren’t needed to establish biosimilar safety.

The broader adoption of biosimilar drugs has the potential to significantly reduce cancer care costs and improve patient access to more affordable treatments, benefiting both patients and payers. However, a recent review highlights that biosimilar uptake has been hindered by various economic, practical, attitudinal, and psychological factors.

British Columbia's 2019 Biosimilars Initiative, which transitioned over 40,000 patients from costly reference biologics to biosimilars, saved around $732 million in 5 years, maintained comparable health outcomes, and reinvested the savings to improve the province's public payer program.

In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.

A poster from the European Hematology Association’s (EHA) 2024 annual meeting in Madrid, Spain, showed similar rates of transfusion avoidance between patients with paroxysmal nocturnal hemoglobinuria who were administered reference eculizumab (Soliris) and those administered an eculizumab biosimilar (SB12).

Posters from the American Society of Clinical Oncology annual meeting showcased safety and efficacy data for a trastuzumab biosimilar and an ado-trastuzumab biosimilar in HER2-positive (HER2+) cancers.

Authors of an integrated literature review identified 7 themes that help stakeholders define the value of biosimilar portfolios beyond cost savings, which could provide stakeholders better clarity as to the value of a biosimilar portfolio vs a single biosimilar within a portfolio.

Cencora's Lakesha Farmer, PharmD, MBA, discusses efforts that health care organizations can take to better educate patients and providers on biosimilars to improve biosimilar acceptance and achieve cost savings associated with these products.

American and European regulatory agencies have provided companies with good news, with several biosimilar candidates seeing application acceptances or approvals in Europe.

Posters from the American Society of Clinical Oncology (ASCO) 2024 annual meeting demonstrate positive safety and efficacy data for denosumab and pegfilgrastim biosimilars.

In a position paper from the Biosimilars Council, the organization points to evidence showing that clinical efficacy trials are a major barrier to biosimilar access in the US, calling for the FDA to change its policies to remove them in favor of other comparators.

On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars, as well as the feasibility of switching to them.

Posters from Digestive Disease Week 2024 look at how super-responders and pregnant patients with inflammatory bowel disease (IBD) react to treatment with subcutaneous infliximab and an infliximab biosimilar, respectively.

May proved to be a big month for biosimilar research, particularly in the gastroenterology space, where new data on infliximab and adalimumab products from conferences and journals alike demonstrated positive clinical results showcasing the safety of these products as well as switching to them.

The FDA approved Bkemv (eculizumab-aeeb) as the first biosimilar to Soliris (eculizumab) for 2 rare diseases. It was also approved with interchangeability.

A literature review revealed new data demonstrating that biosimilar-to-biosimilar switching is safe and effective.

Alvotech and Teva have launched Simlandi in the US; Xbrane Biopharma and STADA Arzneimitel partner with Valorum Biologics to bring a ranibizumab biosimilar to the US; Boehringer Ingelheim and Celltrion take steps to expand access to their respective adalimumab biosimilars.

Lakesha Farmer, PharmD, MBA, from Cencora discusses innovative pricing and reimbursement models incentivizing biosimilar adoption and competitiveness, including dual pricing strategies and the Mark Cuban Cost Plus Program, while highlighting potential impacts on patient assistance programs.

Two posters from Digestive Disease Week found that switching patients with inflammatory bowel disease (IBD) from Remicade to an infliximab biosimilar did not impact clinical outcomes, with one study focusing on switches in pediatric patients and the other focusing on patients undergoing multiple switches.

In the IQVIA Use of Medicines in the US 2024 report, biosimilars were found to be large contributors to lower drug costs and drivers of market growth; however, these products account for about 23% of the overall biologics market, showing wide variation in uptake across molecules.

Posters from Digestive Disease Week (DDW) on the ongoing LIBERTY-CD trial assessing Zymfentra, a subcutaneous infliximab product, compared with intravenous infliximab treatment in Crohn disease show the safety and efficacy of the product, as well as the impact of body mass index (BMI) on clinical outcomes.

The FDA approved the first 2 biosimilars referencing Eylea (aflibercept)—Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy)—for the treatment of ophthalmic conditions.

The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.

Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.

At the Festival of Biologics USA, panelists stressed the need for patient-centered communication and education to boost comfort with biosimilars, emphasizing consistent support from health care providers despite restrictive payer policies.

The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.

As Indian pharmaceutical companies supplied 4 of every 10 prescriptions in the US in 2022, generating $1.3 trillion in health care savings, a new IQVIA report highlights concerns about supply chain risks and advocates for partnerships to bolster biosimilar security and overall supply chain resilience.

Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.

On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.

Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.