Biosimilars

2022 Outlook: Notable FDA Approvals, Payer Strategies Are Specialty Trends

The specialty pharmacy industry will continue its growth in 2022, experts tell AIS Health, a division of MMIT. Multiple agents for rare diseases are poised for FDA approval, and the market may see additional cell and gene therapies. In addition, payers will carry on their efforts to keep prices for specialty medications affordable, among other trends.

AIS Health: What are some specialty pharmacy issues to keep an eye on in 2022, and why?

Biosimilar Approvals Are Expected to Undergo Upward Trend in 2022

The FDA approved only four biosimilars in 2021, down from its high of the 10 it approved in 2019, but slightly more than the three such therapies approved in 2020. The agency also granted interchangeability to the first two biosimilars. This year may up the excitement level, industry experts tell AIS, a division of MMIT, with numerous products expected to be approved, while other noteworthy therapies will lose patent protection and potentially face biosimilar competition.

Dea Belazi, Pharm.D., M.P.H., president and CEO of AscellaHealth: The United States has been slow to approve and adopt biosimilars. Since the initial biosimilar approval in 2015, the FDA has approved 33 biosimilars, but only 18 are currently available on the U.S. market with a projected market value of $13 billion in 2021. Even with this slow uptake in the United States, there is increased utilization and a growing pipeline of products that will drive use and savings. In 2021, many blockbuster drugs were approved in the biosimilar space, along with the two interchangeable biosimilar products, [Boehringer Ingelheim Pharmaceuticals, Inc.’s] Cyltezo and [Viatris Inc. and Biocon Ltd. subsidiary Biocon Biologics Ltd.’s] Semglee.

Big 3 Implement Conflicting Formulary Exclusions on Biosimilars

The Big Three PBMs — Cigna Corp.’s Express Scripts, UnitedHealth Group’s OptumRx, and CVS Health Corp.’s Caremark — once again added new drugs to their formulary exclusion lists for the 2022 plan year, but the rate of new exclusions slowed. Industry insiders tell AIS Health, a division of MMIT, that the slowing amount of exclusions indicates the PBMs find high value in opaque, complex contracting agreements with providers, even though certain preferences in areas like insulins, specialty drugs and biosimilars defy the logic of list prices.

According to an analysis of plan documents by Adam Fein, Ph.D., CEO of the Drug Channels Institute, Caremark now excludes 433 products from its formularies, Express Scripts excludes 485 and OptumRx excludes 492. Each amount sets a record number of exclusions for each company.

Cardinal Health Predicts Biosimilar Boom in New Report

Pharmaceutical distribution and wholesaling giant Cardinal Health Inc. is optimistic that biosimilars will be broadly adopted and deliver big cost savings to the U.S. health care system in the next several years. The findings of a new white paper from the company run counter to more pessimistic predictions by other industry insiders, but Cardinal executives tell AIS Health, a division of MMIT, that even though some barriers to biosimilars remain, new approvals and regulatory changes have already accelerated adoption.

“I am deeply encouraged by the progress made in the U.S., especially this past year,” Sonia Oskouei, Cardinal Health’s vice president for biosimilars, wrote in the report. “Following the launch of the first biosimilar in 2015, we now have 33 FDA approved biosimilars with 21 available on the market as of January 2022. The U.S. biosimilars story that was initially described as sluggish and delayed has now transformed to one of progress and momentum. This past year, the promise of biosimilars has started to become a reality, as greater competition for some of the costliest biologic treatments on the market is beginning to drive meaningful cost savings.”

New FDA Approvals: FDA Approves Additional Indication for FoundationOne CDx | Jan. 13, 2022

Dec. 8: The FDA gave another approval to Foundation Medicine, Inc.’s FoundationOne CDx as a companion diagnostic for current and future BRAF inhibitors used to treat melanoma, including monotherapies targeting BRAF V600E and BRAF/MEK inhibitor combination therapies targeting BRAF V600E or V600K mutations. The agency first approved the test on Nov. 30, 2017.

Dec. 9: The FDA granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to help identify people with non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 20-insertion mutations who may be candidates for treatment with Rybrevant (amivantamab-vmjw) from Janssen Biotech, Inc., a Johnson & Johnson company. The agency initially approved the test on June 22, 2017.

Looking Forward to 2022, COVID-19 Will Continue to Impact Pharma in Myriad Ways

As 2021 began, the pharmaceutical topic arguably drawing the most attention was COVID-19 and the rollout of vaccines against it. Moving into 2022, the COVID pandemic unfortunately continues to dominate headlines, as the U.S. marked 1 million new cases of COVID on Jan. 3, a single-day record for any country. However, it’s not all bad news, as the pandemic is continuing its impact across various services. For example, drugmakers are applying knowledge gained in their innovative efforts to develop vaccines and treatments to other areas of drug development, and a shift to virtual operations and health care is expected to continue.

AIS Health spoke with a variety of industry experts about their 2022 projections for pharma.

News Briefs: Monoclonal Antibodies Yield Mixed Results Against Omicron | Dec. 22, 2021

Regeneron Pharmaceuticals’ monoclonal antibody treatment for COVID-19 has “diminished potency” when used against the omicron variant, while AstraZeneca plc’s antibody product “retained neutralizing activity” against the new variant. The antibody treatments remain the standard of care for unvaccinated COVID-19 patients with severe disease. Regeneron emphasized that its treatment is effective against the delta variant. However, omicron has become the dominant variant in recent days: the Associated Press reported 73% of new infections last week were omicron.

Innovative New Drugs, Collaborative Efforts, Digital Health Care Deals Were Among 2021 Trends

While the COVID-19 pandemic still drove a lot of the conversation around the pharmaceutical industry over the past year, much of it was focused on the development of vaccines and their rollout starting in late 2020, as well as treatments for the virus. But other innovative agents also came to market in 2021, continuing the industry’s trend of producing pioneering products. AIS Health, a division of MMIT, spoke to industry experts about the impact of COVID-19 on the industry and other 2021 pharma trends.

FDA Grants Interchangeable Status to Humira Biosimilar, but Certain Factors May Hamper Its, Other Adalimumabs’ Uptake

Less than three months after granting interchangeable status to a biosimilar for the first time, the FDA has approved that status for a second biosimilar, Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm). It and multiple other biosimilars of AbbVie Inc.’s Humira (adalimumab) are slated to come onto the U.S. market in 2023, but plans should be preparing now for the drugs’ launches, say industry experts. Still, a handful of factors could pose an issue with the agents’ taking market share from the reference product.

On Oct. 15, 2021, the FDA granted interchangeability status to Cyltezo for all of its approved uses. Boehringer Ingelheim’s Phase III VOLTAIRE-X clinical trial found no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity and safety over multiple switches between Humira and Cyltezo. Per the Biologics Price Competition and Innovation Act (BPCIA) of 2009, the drug will have one year of exclusivity upon launch during which the FDA cannot grant interchangeable status to another Humira biosimilar.

FDA Grants Interchangeable Status to Humira Biosimilar; Payers Should Prepare Now for 2023 Launches

Less than three months after granting interchangeable status to a biosimilar for the first time, the FDA has approved that status for a second biosimilar, Boehringer Ingelheim Pharmaceuticals, Inc.’s Cyltezo (adalimumab-adbm). It and multiple other biosimilars of AbbVie Inc.’s Humira (adalimumab) are slated to come onto the U.S. market in 2023, but plans should be preparing now for the drugs’ launches, say industry experts. Still, a handful of factors could pose an issue with the agents’ taking market share from the reference product.