The value and benefits of biosimilars are increasingly becoming more apparent, according to experts.
“Biosimilar growth will lead to a more competitive market, price decreases for payers and improved access to treatment for patients,” says April M. Kunze, PharmD, senior director, Clinical Formulary Development and Trend Management Strategy, Prime Therapeutics. “That said, physicians need to prescribe biosimilars more to help increase their market share in comparison to brands.”
Biosimilars will experience growth, but it will largely be driven by each category and what the original brand drug makers do as the patents expire and how crowded the categories become, according to Mark Ginestro, a principal at KPMG Strategy who works with life sciences companies.
“Some segments have become very competitive, particularly TNF-inhibitors used for rheumatoid arthritis, Crohn’s disease and other autoimmune disorders,” Ginestro says. “Broadly speaking, the makers of biosimilars had expectations that they’d be able to sell their products 15% to 30% below the brand name manufacturers price, but this discount is dependent on a myriad of market factors including but not limited to the position of the brand, the competitiveness of the current market, the number of biosimilar competitors, and the patient/physician pathway and experience.”
This being said, demand for biosimilars could be high, as health plans look to steer patients that way, according to Ginestro. “However, originators of the drugs have largely recouped the costs of developing the products so there is a lot of pricing flexibility on their part that could keep certain therapeutic categories competitive.”
Globally, biosimilars will experience robust growth, according to Louis Tharp, executive director and cofounder of Global Healthy Living Foundation, a patient-centered non-profit organization whose mission is to improve the quality of life for people with chronic illness, and CreakyJoints, a digital community and advocacy organization for arthritis patients and caregivers.
However, Tharp says that in the U.S, growth is not guaranteed because of the purchasing and distribution system for infused as well as injectable and auto-injected drugs.
“The presence of middlemen such as PBMs and payers, as well as the buy-and-bill system for infused drugs create odd incentives, almost all of which work against biosimilar uptake,” Tharp says. “Once the U.S. system is sorted out, either voluntarily, or because it implodes at some point, opportunities for biosimilars open up. The U.S. biosimilar market is a long-term bet, additionally disadvantaged by the fact that innovator biologics have the flexibility to meet or beat any price when price is an issue, and meet or beat any rebate plan because they already have the volume.”
There are currently 14 biosimilars approved in the U.S. for eight originator products. Of the 14 approvals, only six of the biosimilars have launched:
- Zarxio and Nivestym, biosimilars to Neupogen
- Fulphila, biosimilar to Neulasta (with Udenyca expected to launch shortly)
- Inflectra and Renflexis, biosimilars to Remicade
- Retacrit, the biosimilar to Epogen/Procrit
The remaining approvals cannot launch due to ongoing patent litigation, according to Kunze.
“Biosimilar launches have stimulated competition in the market, reducing the price of the brand products through increased rebates and other contracting strategies,” Kunze says. “Biosimilars are typically less expensive than the reference biologic. Competition saves payers and members money, and increases access and choice for patients and clinicians.”
The biosimilars that are approved and launched are mainly adjudicated on the medical benefit; therefore, average wholesale pricing (ASP) strategies are in place which take time to equilibrate and require physicians and health systems to adopt biosimilar strategies and negotiate best prices. Prime Therapeutics has worked closely with our health plans to outline the various pricing strategies and proposed strategies to support biosimilar growth, according to Kunze.