The Growth of Biosimilars in the Oncology Pipeline

Slowed by years of regulatory and legal hurdles, the emergence of biosimilars in the U.S. market is now rapidly advancing — particularly in the oncology space, where these products hold the potential to increase access and provide lower-cost alternatives to cancer care.

Biosimilars, which have been available in Europe for about a decade, represent a new, hybrid category — unique from both innovator brands and generic products.

Since 2015, the Food and Drug Administration (FDA) has approved five new biosimilars, including Zarxio (filgrastim-sndz), a supportive therapy approved for patients with cancer. Experts, however, predict that number will surge in the coming years, driven by the nationwide push to reduce healthcare costs and the $100 billion worth of biologics that will lose patent exclusivity worldwide by 2020.¹ Fueled by the looming patent expirations and increased competition among pharmaceutical manufacturers, the biosimilar market in the United States is expected to grow from $1.7 billion in 2014 to $30 billion by 2020² — a rapid increase that will be prominently reflected in the oncology pipeline.

Currently, there are no approved therapeutic oncology biosimilars available in the United States. However, the biosimilars of two blockbuster cancer therapies — Avastin and Herceptin — are on the verge of FDA approval after receiving unanimous support from the FDA’s Oncology Drugs Advisory Committee on July 13. The landmark recommendations mark a significant step forward in bringing therapeutic oncology biosimilars to patients in the United States and pave a path for current and future biosimilar products in the oncology pipeline. Today, about 30 percent³ of all biosimilars that await FDA approval are monoclonal antibodies, highlighting the potential for a wave of new therapies to enter the market that could yield improved patient access and affordability.

In order to capitalize on the promise of biosimilars, manufacturers must account for the unique needs throughout the development and commercialization process to ensure timely regulatory approval, optimal market access and maximum uptake among providers. Given today’s healthcare landscape, biosimilar manufacturers must also consider the following factors: provider education and awareness, increasing competition and patient support.

Importance of education to maximize provider uptake

Despite meeting the same safety and efficacy requirements of innovator biologic reference products, biosimilars — unlike small molecule generic drugs — are not considered by the FDA to be interchangeable with their reference products.
 
On January 17, 2017, the FDA issued long-anticipated guidelines on demonstrating interchangeability with a reference product — a step toward more clearly defining the regulation of interchangeability. But the lack of a label carries implications, especially among healthcare providers, who typically use an interchangeable product as a substitute because it produces the same clinical result. As a result, manufacturers must educate — or seek partners that can leverage their strong network and expertise to inform — healthcare providers about the safety and efficacy of biosimilars, as well as the rigorous process the products undergo prior to approval.

It is critical to ensure healthcare providers not only feel confident administering biosimilars, but also comfortable with the reimbursement process and available patient support services, so there is no disruption to the practice’s operational workflow.

Manufacturers can prepare providers for the upcoming changes and build provider confidence through a multi-channel, education-based approach. Manufacturers can prepare providers and build provider confidence through a multi-channel, education-based approach. As an example, ION Solutions reaches more than half of the community-based oncology practices in the country and often works with manufacturers to leverage those relationships to communicate product-specific messages. Live meetings and symposia can provide oncologists with the science behind biosimilar development and offer data that demonstrates the efficacy of these products, highlighting clinical studies and the corresponding patient outcomes.

Planning for market competition & patient and provider needs

Therapeutic oncolytic biosimilars have the potential to emerge as long-term, sustainable cancer treatment options that come at a lower cost for both patients and practices. While the first biosimilar entrants for unique indications could drop the market price by 10 to 15 percent, experts predict that percentage will increase in the future when there are two to three competitors for the same molecule.

Given the increasingly competitive marketplace, biosimilar manufacturers may seek to uncover existing market needs not served by the innovator biologic or any current biosimilars. Once competition increases, it will require more creative strategies to gain market share, making it more important that a commercialization strategy first and foremost meets the needs of the patients and providers who will use their products.

With potential challenges around costs and coverage, biosimilar manufacturers will have to offer reimbursement support and patient assistance programs, such as co-pay programs, in order maximize patient access and provider uptake. Given the complex nature of biosimilars, it is critical to provide hub services to ensure patients are educated on proper administration, management, handling and storage — key factors that will drive improved patient access and adherence. The services also help patients navigate insurance hurdles, ensure they understand the benefits and requirements of the biosimilar product and help them achieve the best possible outcomes.

In order to achieve sustained success, biosimilar manufacturers need to anticipate how the growth in competition and burgeoning oncology pipeline will shape the market moving forward. Commercialization and channel strategies must evolve. Manufacturers should focus their efforts — or enlist a partner — to work with providers to address unmet market needs and support the patients who will use their products and the oncologists who will prescribe them. Through that integrated approach, manufacturers, patients and healthcare providers will be able to capitalize on the promise of oncology biosimilars.