Pfizer Supports Affordable Access Through Biosimilars
September 20, 2021
Biologics are complex medicines such as vaccines, gene therapies and monoclonal antibodies that are built from parts of living organisms like plants or proteins. They have revolutionized the treatment of cancer, autoimmune conditions and other diseases. But they often carry a high cost.1
As patents for biologics expire, biosimilars, which work in the same way and have the same strength and dosage as biologics, may provide the same benefits to patients at lower cost.
Pfizer has invested strategically in biosimilars, increasing access to essential medicines and delivering value for the company. Pfizer saw the revenues grow operationally by 88 percent to $559 million in the second quarter2, while giving some patients a potentially more affordable treatment option.
A potentially quicker path to authorization
Biologics are created in living cells and have a complex protein structure that is not easy to reproduce.
Biosimilars must also go through rigorous research and testing to show they’re highly similar to the original biologic medications and must be manufactured to the same high standards of purity, chemical identity and bioactivity as the original products.3 The original biologics are referred to as the reference or innovator product.
Since biosimilars are based on a product that is already approved, they can have a faster path to authorization. To be approved by the FDA, a biosimilar manufacturer must demonstrate that its candidate has “no clinically meaningful differences in terms of safety and efficacy” from the reference product.
“There’s a lot of work that goes into designing a biosimilar program to efficiently show that it has exactly the same performance as the innovator,” said Pfizer’s Martin Summers, Medicine Team Leader for biosimilars.
Leading the way in biosimilars
Pfizer has been a pioneer in developing biosimilars for more than a decade. The company’s leaders believe patients should have access to affordable options for their conditions.4
The company has recently received regulatory approval for several biosimilars.
“Biosimilars have become a meaningful part of our business while delivering lower-cost patient care options.”
Albert Bourla, Chairman and CEO, Pfizer
In 2020, Pfizer received FDA approval for NYVEPRIA® (pegfilgrastim-apgf), a biosimilar to pegfilgrastim, which is used to treat a relatively common side effect of some cancer treatments.5
In the European Union, the company received approval for RUXIENCE™ (rituximab-pvvr). Like the biologic reference product, it’s used to treat certain blood cancers.6
“Biosimilars like RUXIENCE™ have the potential to deliver real value in healthcare, improving access to and affordability of an important cancer treatment which could help more patients receive optimal care,” said Andy Schmeltz, Global President of Pfizer Oncology.7
With advances in developing biosimilars, patients could benefit with increased access to these medicines.
“Biosimilars have become a meaningful part of our business while delivering lower-cost patient care options,” said Albert Bourla, Chairman and CEO of Pfizer.
[1] Biologics vs Biosimilars: Understanding the differences. Available here.
[2] Pfizer Reports Second Quarter 2021 Results. Available here.
[3] Biosimliars: Advancing Science to Help Improve Patient Access to Medicines. Available here.
[4] Q2 2021 Pfizer Inc. Earnings Call. Page 4. Available here.
[5] FDA Approves Pfizer’s Oncology Supportive Care Biosimilar Nyvepria™. Available here.
[6] Pfizer Receives European Approval for Oncology Biosimilar, Ruxience™. Available here.
[7] FDA Approves Pfizer’s Biosimilar, Ruxience™ (Rituximab-PVVR) for Certain Cancers and Autoimmune Conditions. Available here.