Memo in Support of New York Sate Biosimilars Legislation


Memorandum in Support A.7509(Gottfried); S.4788(Hannon)

 

Relates to interchangeable biological products

NewYorkBIO strongly supports A.7509 and S.4788, which would establish requirements for pharmacies to substitute and dispense interchangeable biological products.  This legislation updates New York’s laws regarding the substitution of generic drugs to reflect the more complex nature of emerging biologic therapies.  This update is necessary both to allow for the substitution of biologics in New York (which should lead to cost savings for consumers and to provide safeguards for patients to ensure they receive the most efficacious treatment possible.    

Biologics are cutting-edge therapies that are manufactured in a living system (like a plant or animal cell).  Most biologics are very large, complex molecules produced using recombinant DNA technology. These are drugs that target spinal cord injury, kill cancer cells and treat inflammatory diseases; attack Alzheimer's, diabetes and heart failure; and address genetic disorders, addiction, and even alopecia.

Biologics differ from tradition drug therapies that are manufactured through chemical synthesis.  A traditional drug can be analyzed with specificity to ensure that it was manufactured with the exact chemical composition intended.  Thus, once a brand drug has lost its patent protection, the FDA can determine if a proposed generic version of that drug is “bioequivalent” to the brand drug.  Analogously, New York law provides a fairly straightforward process by which pharmacists can substitute generic drugs for name brand drugs.

Fundamentally, the present legislation ensures patient safety and access to innovative treatments by creating a pathway to bring biosimilars to consumers.  Addressing difficult maladies with biologics requires absolute certainty with regard to a treatment’s interaction with a patient’s system.  This legislation would update the New York law regarding drug substitution to require that a substitute biologic be “interchangeable” with a prescribed biologic.  Federal law defines whether a biologic meets the standard of “interchangeable” - a different standard that reflects the more complex nature of biologic products.  

Moreover, it contains transparency provisions which are critical to both prescribers and patients.  It is for this reason that 18 health care advocacy groups support this legislation, including the American Cancer Society - Cancer Action Network, the Global Healthy Living Foundation, the Latino Commission on AIDS, the Lupus and Allied Diseases Association and the Scleroderma Foundation Tri-State Chapter.  

In recent years, 31 other states have updated their substitution laws to reflect the distinction between traditional drugs and biologics, including California, Pennsylvania, New Jersey, Ohio, Washington, and Oregon

Conclusion

For the reasons set forth above, NewYorkBIO strongly supports this proposal.  For further inquiries, please contact Joe Tortorice, VP, Operations & Business Development at joe@newyorkbio.orgjoe@newyorkbio.org or (212) 433-2623

About NewYorkBIO

NewYorkBIO is the leading trade association for the life sciences industry in New York City and New York State, representing more than 250 biomedical companies, universities, research institutions, and others dedicated to advancing life-saving research. New York is the largest and richest bioscience community in the world. With the largest concentration of academic research centers in the world, New York graduates more PhDs than any other region in the country and is responsible for a quarter of all cancer clinical trials. The life sciences employ more than 75,000 New Yorkers at companies ranging from very small start-ups that rely on incubator space to the largest pharmaceutical companies in the world.