Biologics & Biosimilars

Biologics & Biosimilars

We are building our biologics pipeline and delivering high-quality biosimilar products to help meet the growing needs of patients and health care systems worldwide.

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Biologics have revolutionized the treatment of patients suffering from some of the most debilitating and life-threatening diseases, and the potential for discovering novel biological therapies remains high.

In addition to our robust and expanding pipeline of originator biotherapeutic candidates designed to address unmet medical needs, we believe high-quality biosimilars that are functionally and physically equivalent to existing biotherapeutics can facilitate access to these lifesaving biological medicines for patients across the globe, while respecting the intellectual property rights of the originator. A biosimilar product is highly similar to its approved reference product, with no clinically meaningful differences in terms of the safety, purity and potency of the product.

PORTFOLIO AND PARTNERSHIPS

We are developing a diversified portfolio of innovative biotherapeutic candidates targeting several important clinical indications, including oncology (building on our expertise in immune-oncology), infectious diseases, neurobiology, cardiovascular and metabolic disease.

In February 2015, we entered into a broad strategic collaboration with NGM Biopharmaceuticals, Inc. (NGM Bio) to discover, develop and commercialize novel biologic therapies across a wide range of therapeutic areas. The collaboration includes multiple therapeutic candidates currently in preclinical development at NGM Bio, including NGM282, which is being evaluated for the treatment of diabetes, obesity and nonalcoholic steatohepatitis (NASH).  Most recently, NGM Bio announced the results from a Phase II study of NGM282 in NASH patients, which demonstrated clinically significant improvements in liver histology after 12 weeks.

In 2013, we entered into an agreement with Samsung Bioepis Co., Ltd. to develop and commercialize multiple biosimilar candidates in our partnered territories. Since that time, this partnership has made significant progress on a portfolio that includes biosimilar candidates in immunology and oncology, with a number of biosimilars either already approved or expected to be filed with regulatory authorities in our territories. Through April 2018, RENFLEXIS (infliximab) has been approved in Australia, Canada and the United States; BRENZYS (etanercept) has been approved in Australia and Canada; and ONTRUZANT (trastuzumab) has been approved in the European Union.

PUBLIC POLICY

Our advocacy position on biologics and biosimilars is built upon a foundational objective of seeking to improve health outcomes while maintaining patient safety. All of our policies associated with biologics, biosimilars or any other drug regulation are motivated first and foremost by our focus on the patient.

Our advocacy recognizes the complexity of all biologic products, both innovator biologics and biosimilars, and seeks to establish sound policy parameters for the development and use of biologics to ensure that patients have access to high-quality, safe and effective medicines. Our policies regarding biologics and biosimilars are based on science, and reflect a balanced approach consistent with our status as a developer of both biosimilars and originator biologics.