The Issue

Biologics are complex medicines manufactured from living organisms. Unlike traditional “small molecule” drugs, biologics are not chemically synthesized but rather are manufactured from living cells by programming a particular cell line to produce a desired therapeutic substance in a highly controlled sterile environment. Each individual biologic therapy is a complex, heterogeneous mixture, which in many cases cannot be well characterized by current science. Because of this complexity, even minor differences in manufacturing processes can cause variations in the end product. Consequently, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same.

Follow-on biologics, or “biosimilars,” are biologic products manufactured using different cell lines and manufacturing processes with the goal of closely mirroring the composition and treatment profile of an innovator product produced by another company. Due to the innate complexity of biologics in general, however, the production of biosimilar products will invariably lead to some differences between the composition of a biosimilar and the original innovator product, and these differences could potentially lead to clinical differences in a patient’s experience or reaction. In other words, unlike generic copies of traditional small molecule drugs, biosimilar biologic products will be therapies that are similar to, but not the same as, an innovator therapy.

Our Position

MassBio believes that a sound policy in Massachusetts outlining parameters for safe substitution of interchangeable biologics is the best option to ensure patients have access to high-quality, safe, and effective biologic medicines. MassBio’s core concerns are to safeguard patient safety and the primacy of the physician-patient relationship, recognizing that treating physicians and their patients are in the best position to determine appropriate therapies.

MassBio waits as the FDA develops appropriate standards for the approval of safe biosimilar and interchangeable biologic products in order to best protect patient safety.

We support the BIO Priniciples on Patient Safety in the Substitution of Biologic Products.



About MassBio

MassBio is a not-for-profit organization committed to advancing Massachusetts' leadership in the life sciences to grow the industry, add value to the healthcare system and improve patient lives.

Founded in 1985, MassBio represents over 650 biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and health care, and works to advance policy and promote education, while providing member programs and events, industry information, and services.

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