The Center for Biosimilars® provided news and insight during June 2021 in the form of interviews with key opinion leaders and coverage of major events. Catch up on what you missed.
The month of June 2021 saw many developments for biosimilars. The Center for Biosimilars® was on top of this news. Below is a selection of leading headlines that appeared during the month.
Amgen Senior Counsel on Interchangeables
The first interchangeable biosimilars are just around the corner, according to industry insiders, and these products are most likely to be insulins, for which there are currently no biosimilars. As Laura Sim, senior counsel at Amgen explained in a recent presentation, there are many unknowns with interchangeables. What happens if product lines evolve after biosimilars are granted interchangeable status? Will payers tend to give interchangeables higher formulary status than biosimilars?
It could turn out that interchangeables create more problems than they solve.
Cigna and the $500 Health Care Debit Card
Taking a page out of the COVID-19 vaccine book, Cigna is offering patients a cash award if they make the switch to money-saving biosimilars. Biosimilars advocates often wonder how deep the payer commitment is to biosimilars, and Cigna seems to be providing an answer with this debit card offer. The program rolls out in July 2021.
Can a Delayed Biosimilar Introduction Be a Good Thing?
Pay-for-delay settlements between originator companies and biosimilar developers have a bad reputation. It is assumed that both sides get something in the deal and patients and payers end up being the losers, because access to lower-cost medicines is denied. But Karin A. Hessler, assistant general counsel for the Association for Accessible Medicines, noted in a recent presentation that these settlements may avoid costly litigation that would otherwise delay biosimilar market entry for many more years—so, they actually help patients out.
Taking on the Patent Makers
Tahir Amin, Dip LP, formerly concocted patents for drug companies specifically to stretch out product exclusivities and keep competing products off the market. This line of work bothered his conscience and now, as co-executive director of I-MAK (The Initiative for Medicines Access and Knowledge), he’s a leading advocate for breaking down patent barriers to broader access to lifesaving medicines.
His interview on AbbVie, Humira, and patent thickets can be found here.
Deploying Biosimilars for Savings
The COVID-19 pandemic created a financial crisis for health care institutions, one that many are still trying to recover from. In an eloquent column, Sophia Z. Humphreys, PharmD, MHA, argues that if biosimilars have yet to fulfill their potential as money savers, now is their chance. Health care institutions have already demonstrated savings with these agents and these agents could help fix the COVID-19 financial imbalance, says Humphreys, director of System Pharmacy Clinical Services for Providence St. Joseph Health in Renton, Washington.
Tenderizing the Tender System in Europe
Biosimilar procurement in the European Union often depends on “tender” contests between drug producers, with the lowest-cost product often getting the contract. These procurement strategies may cause more harm than good, authors of a new survey contend. They argue for multi-winner bidding contests and a much broader range of criteria than cost for judging which biosimilars are chosen.
Alvotech’s Game Plan for Adalimumab
When it comes to biosimilar wars, there’s no shortage of action in the adalimumab arena. One of the contenders is Alvotech, of Reykjavik, Iceland, which hopes to score with a high concentration, citrate free formulation of this blockbuster medicine. Anil Okay, chief commercial officer for Alvotech, explains the company’s strategy in this video interview.
Copy Biologics in India
India is a case example of a developing nation that cannot yet produce biologics according to Western standards, although individual companies are standouts. The country has been ratcheting up its guidelines with the goal of meeting globally accepted quality criteria, and in this 2-part interview, a trio of panelists discuss these efforts and the potential for change.
Supreme Court and the Individual Mandate
A lot of work went into creating the biosimilars approval pathway, which is embodied in the Biologics Price Competition and Innovation Act (BPCIA) portion of the Affordable Care Act (ACA). So, it was a relief to biosimilars advocates in June when the nation’s highest court rejected a petition to strike down the whole of the ACA, including the BPCIA.
The court accomplished this rejection with subtlety of a tai chi master, using the minimum amount of legal leverage. In essence, it simply told plaintiffs they were not qualified to bring their suit. The court, as legal experts pointed out, never had to “address the merits” of the case.
Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings
May 16th 2024Two 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.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On 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.
Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches
May 14th 2024The 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.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment
May 4th 2024A review article summarizes the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.