The Florida Alliance for Healthcare Value hosted a webinar on September 22, 2020, in partnership with its affiliate member Amgen. Chad Pettit, Amgen’s Executive Director of Marketing and Global Biosimilars Commercial Lead, shared highlights of the company’s 2020 Biosimilar Trends Report.
What is a Biosimilar?
A biosimilar is a biologic drug that is highly similar to and has no meaningful differences from a biologic that is already approved by the FDA (also known as the originator biologic or reference drug). Biosimilars are not the same as generic medicines which are small-molecule drugs with the same structure as their reference drug. In contrast, biosimilars are large-molecule drugs that are much more structurally complex and highly similar in structure to their reference biologic.
Because they rely on the FDA’s previous safety and efficacy findings for the reference drug, biosimilars can be developed quicker and less expensively than their reference biologic with fewer clinical trials and studies. Biosimilar developers instead focus primarily on demonstrating “biosimilarity” to the reference drug.
Key Benefits of Biosimilars
Increasing specialty drug costs create challenges for employers trying to control healthcare costs. Biosimilars can generate cost savings in two primary ways without sacrificing quality, efficacy or patient safety:
- Introducing additional treatment options
- Increasing competition in the marketplace, causing manufacturers to lower prices
Changes and Trends in the Biosimilar Industry
- Interchangeability and Switching – U.S. pharmacy laws require that a biosimilar be designated by the FDA to be “interchangeable” with its reference drug for a pharmacist to recommend substitution. FDA final guidance on this subject was provided in May 2019 and indicates that manufacturers should conduct one or more “switching studies” to assess the safety and effectiveness of alternating between the reference drug and the biosimilar.
- Reimbursement Environment – With CMS reimbursement systems changes, including separate HCPCS codes and payment rates, the U.S. reimbursement environment is starting to level the playing field and support the use of biosimilars.
- Market Growth – The U.S. marketplace for biosimilars is beginning to accelerate, growing to a total of 28 FDA-approved biosimilars as of 2020 (a 157% increase over 2019) with 18 biosimilar drugs now available to patients. This includes drugs for several conditions, including cancers and autoimmune diseases. Biosimilars are now approved for the following biologics: filgrastim (NEUPOGEN), pegfilgrastim (Neulasta), bevacizumab (Avastin), trastuzumab (Herceptin), infliximab (REMICADE), epoetin alfa (EPOGEN/PROCRIT), rituximab (Rituxan), etanercept (Enbrel) and adalimumab (HUMIRA). While approved, the biosimilars for etanercept and adalimumab are not yet commercially available.
- Increased Uptake – As more biosimilar drugs launch, providers and insurers are becoming more comfortable with them. The biosimilar for filgrastim has been on the market the longest (since first quarter 2015) and now holds 72% of the market share.
- Provider Education – Science-based education efforts are critical to building healthcare professionals’ confidence in prescribing biosimilars. A 2018 survey of providers conducted by the Health Research Institute of PriceWaterhouseCoopers found that 55% of clinicians were unfamiliar with biosimilars, and 35% of physicians had never prescribed one. The FDA, American Society of Clinical Oncology (ASCO), Biologics Prescribers Collaborative, Pharmaceutical Research and Manufacturers of America, and Biotechnology Innovation Organization have all launched educational campaigns to help bridge the knowledge gap. Oncology is the specialty that currently seems most familiar and comfortable with use of biosimilars.
- Patient Education – Informing patients is also key to increasing utilization of biosimilar drugs. This includes education on safety, effectiveness and cost savings, including access to patient assistance programs when available.
The Role of Payers and Employers
Payers such as United HealthCare and pharmacy benefit managers like Prime Therapeutics are starting to embrace the use of certain biosimilars. When considering adding biosimilars to their formularies, the primary considerations of payers and employers include the following:
- Existing clinical trials and post-marketing evidence
- Utilization management mechanisms
- Physician willingness to prescribe them
- How they will be covered and placed on the formulary
- Whether, how and when to switch patients to biosimilars
- Potential to decrease costs while maintaining patient access to necessary treatments
In addition, the National Alliance of Healthcare Purchaser Coalitions has outlined four steps for employers to influence change:
- Quantify the biosimilar opportunity by initiating conversations with vendors about fill rates and savings potential.
- Review specialty pharmacy benefit design to ensure that it supports appropriate use and access.
- Partner with vendors to determine how best to drive appropriate promotion, adoption and utilization of biosimilars.
- Educate all employees about the value of biosimilars to enable more informed decision making.