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Biosimilars Roundup: November Was Dominated by Legislative and Regulatory News


Regulators are at work clarifying biosimilar guidance and on Capitol Hill, a battle is raging over reforms that could help or hurt biosimilar advancement.

November 2021 was a busy month on the biosimilars front, with companies announcing plans for interchangeable forms of adalimumab, the FDA stepping back into its normal routines after the COVID-19 battering, and payers putting more weight behind biosimilars.

In Washington, DC, legislators debated health care policies that would promote the use of biosimilars and generics;and biosimilar industry veterans warned of policies that might do more harm than good.

The following is the short list of leading biosimilar news articles published at The Center for Biosimilars®. Read them to ensure you’re on top of events.

News Roundup

Amgen indicated it has a trial under way to qualify its adalimumab biosimilar (Amjevita) for interchangeable status, which would give pharmacists independent latitude to dispense this product in place of the brand, Humira. 

Janet Woodcock, MD, acting commissioner of the FDA

I am pleased to say that as of July we began resuming normal operations for domestic inspections.

Also this month, Pfizer announced that it too intends to seek interchangeable status for its adalimumab biosimilar (Abrilada). That FDA filing, it said, would come in December.

Interchangeability raises questions about the difference, if any, between biosimilars that have the interchangeable designation and those that don’t. The FDA stated in a November conference that it was attempting to tie up some of the loose ends around these 2 designations. Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars, stated that the pending guidance would help with the development of interchangeable biosimilars.

Biosimilars are generally cheaper than the biologics they reference, but payer authorizations and preferences can make the difference between a biosimilar that gets used and doesn’t get used. Prime Therapeutics in November announced it was moving Semglee, an insulin glargine biosimilar, to the pharmacy benefit manager’s preferred formulary list. Semglee became an interchangeable biosimilar this year, and in October 2021, Express Scripts also gave it preferred status.

Regulatory Changes

The FDA has been distracted by COVID-19 and is now getting back to the business of reviewing biosimilar approval applications, Acting Commissioner Janet Woodcock, MD, reported in a biosimilars industry address in November. Domestic factory inspections, essential for certifying biologics manufacturing quality, are back on track, she said.

A new concept has sprung up in the biosimilars world: tailoring. This refers to deciding evidence requirements for biosimilarity partly on a case-by-case basis. The goal is to streamline the approvals process, cut red tape and unnecessary expense, and, most important, do away with “blunt tool” measures for biosimilarity that add little or nothing to the sum total of evidence.

In November, The Center for Biosimilars® reported on a European Medicines Agency pilot project for trying out a tailoring approach on a handful of biosimilar approval applications. Also, the World Health Organization moved forward with an effort to revise its biosimilar guidance to incorporate a more sophisticated palette of tools for assessing biologics equivalence. The Center for Biosimilars® interviewed Marta Baldrighi, PhD, policy and science officer for Medicines for Europe, about the significance of these revisions.

Kelly Pokuta, vice president and chief trade relations officer for Prime Therapeutics,

This formulary change reinforces Prime's commitment to increasing biosimilar adoption and also demonstrates that we are not beholden to rebates, as we're able to also prefer the lowest net cost therapy.

A Capitol Hill initiative to elbow more competition into the drug markets involved a proposal to allow Medicare to negotiate prices for a limited number of drugs and fine manufacturers who refuse to play ball. These proposals, embedded in the draft Build Back Better Act, have aroused consternation in the manufacturing community, which contends that legislators have been chanting a new policy mantra that misses the mark. The real problems are rebates and excessive patenting, they said in discussions and public statements in November.

November signified robust debate but it also included Global Biosimilars Week, an invention of the International Generic and Biosimilar Medicines Association (IGBA), which chose the occasion to raise the issue of patient access and affordability. Policies need to be clarified and perhaps redrafted, IGBA said, so that the savings from biosimilars trickle down to the individuals who are intended to benefit: the patients.

Clinical Findings

Representatives of the Community Oncology Alliance (COA) this past month discussed an interesting development they’ve observed among COA practices that have been using biosimilars: As biosimilars have been introduced, usage of both biosimilars and their reference products has increased. The conclusion? The competitive pricing appears to be lowering costs overall and enabling more patients to afford these products.

Biosimilars in a standalone setting can provide savings, but they can also be used in combination with other brand products. A study of sintilimab in combination with the bevacizumab biosimilar Byvasda was tried in the ORIENT-31 trial of patients with advanced nonsquamous non–small cell lung cancer. Savings were not evaluated, but a significant improvement in progression-free survival was reported.

Lastly, a copycat whiskey made by a biosimilar expert may not be a biosimilar, but it can still save time and money. Sarfaraz K. Niazi, PhD, wrote in a November column about his laboratory experiment to bypass the years-long whiskey aging process. It doesn’t have to take 12 years or 60 years for a whiskey to absorb the flavor from a wooden barrel, Niazi postulated. He used thermal dynamics to accelerate the process. The end point of the study was taste, and Niazi reports it was pretty good.

For all of these stories and many more from November, visit The Center for Biosimilars® homepage.

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