Leading Biosimilars Headlines From June 2021

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.