Biosimilars

What are Biosimilars?

A biosimilar is a version of a biologic medication that is made by a different company than the one that invented it, with no clinically meaningful differences in terms of safety, potency and purity.

Biosimilars

A biosimilar is not an exact copy of its reference product, but this is normal for biologic manufacturing.

Much like the way the regulatory bodies such as the U.S. Food and Drug Administration (FDA) require clinical trial data and other evidence to approve a biologic, the totality of evidence for a biosimilar candidate must show a robust body of data to demonstrate biosimilarity.

Biosimilars vs. generics

The biosimilar development process is inherently complex and requires a high degree of technical innovation and regulatory expertise.

Unlike small molecule drugs that are chemically synthesized and can be copied exactly in the form of a generic, biologics and biosimilars consist of large complex molecules (e.g., monoclonal antibodies) that are manufactured using living cells, extracted, and purified. Since biologics are cultured from living organisms, it is not possible to develop an identical copy of the reference product. This is also true batch to batch for the reference product and for biosimilars making new versions of the reference product.

Biosimilarity vs. interchangeability

A biosimilar is not Interchangeable unless the FDA says it is. An Interchangeable biosimilar first must meet the high FDA standards of a biosimilar—then, in order to achieve the Interchangeable designation, the FDA requires an additional study of multiple substitutions in patients – known as an Interchangeability study. This study shows how patients do when they are switched back and forth multiple times from a reference product to the Interchangeable biosimilar candidate.

A biosimilar with an Interchangeable designation may be auto-substituted for the reference product by a pharmacist.  Individual state laws control how and whether providers must be notified.

Boehringer Ingelheim Fremont, Inc.

Boehringer Ingelheim is one of the largest producers of biologic medicines in the world. Boehringer Ingelheim Fremont, Inc. is the company’s US biopharmaceutical manufacturing site, producing biologic medicines to support our diverse pipeline, as well as other companies’ biopharmaceuticals on a contract basis.

To date, Boehringer Ingelheim’s Biopharmaceutical Contract Manufacturing business has supported our customers to bring 40 biologics to the market – three in 2020 alone – in therapeutic areas that include oncology, immunology and cardiovascular indications.  

Patient Access

The complexity of biologic medicines makes them expensive to produce, placing a high cost on the healthcare system. The utilization of high-quality, lower cost biosimilars can improve the sustainability of healthcare systems, providing the potential for more patients to benefit from biological medicines.

We are leveraging our pharmaceutical expertise in parallel tracks. Through novel biologics and biosimilar programs, we hope to increase the availability of safe, effective, high-quality therapeutic options to patients worldwide.

Benefit of reduced cost to healthcare system

The RAND Corporation has projected that the use of biosimilar medicines in the US will reduce direct spending on biologics by $54 billion from 2017 to 2026.

Collaboration

Boehringer Ingelheim believes that new advances in biologic treatments and processes can be achieved by partnering with healthcare professionals, payers, employers and patient associations. Working together, we can deliver solutions that bring value to the entire healthcare community and improve the treatment journey of our patients with their biologic medicines.

Bringing value to the healthcare community

Our fundamental mission is to make the lives of patients better. We listen, we take the time to understand, and through meaningful and impactful partnerships, we aim to create a lasting difference.

Organizational partnerships

We are also proud to partner with and be a founding member of several organizations committed to raising biosimilar awareness, education and access, including the Biosimilars Forum and the Biologics and Biosimilars Collective Intelligence Consortium.

 

 

Advocacy

Boehringer Ingelheim is proud of the role we play in raising public awareness of biosimilars as well as the importance of stimulating a competitive marketplace to bring more affordable treatment options to US patients. 

Advocating for increased access to biosimilars

Boehringer Ingelheim is supportive of progressive reimbursement and market access policies that will bolster adoption and access of biosimilars in the U.S. market. We believe that incentives across all stakeholders including patients, physicians and health plans must be created to stimulate biosimilar utilization. We support policies across federal programs to implement these incentives.

Filing of Citizen Petition
Boehringer Ingelheim has filed a Citizen Petition asking FDA to correct its interpretation of the term “strength” as used in the Biologics Price Competition and Innovation Act (BPCIA).

Boehringer Ingelheim believes the actions requested in this petition will benefit patients and the US healthcare system, potentially leading to more robust biosimilar development and use, and reduce anti-competitive behavior within the biosimilars industry.