Governor Greg Abbott recently signed legislation into law that enables the substitution of interchangeable biologic medicines in Texas after the passage of the bill in the Texas House and Senate. The decision is expected to increase patients’ access to treatments and has already been praised by the Biotechnology Industry Organization (BIO) and the Texas Healthcare & Bioscience Institute (THBI).
House Bill 751 was signed into law by Governor Abbott on June 19th, after it had passed in the Texas House and Senate the month before. According to the law, the U.S. Food and Drug Administration (FDA) is responsible for the process of approving biologic medicines and awarding the designation of interchangeability.
Additionally, the new law, which will go into effect on September 1st, states that determined products can be used instead of prescription medication, and pharmacists are legally required to inform patients about their options, including both brand and substitution products. The approval of the bill was highly anticipated, as it is expected to expand patients’ access to medication at lower costs.
“It is the intent of the legislature to save consumers money by allowing the substitution of lower-priced generically equivalent drug products for certain brand name drug products and the substitution of interchangeable biological products for certain biological products and for pharmacies and pharmacists to pass on the net benefit of the lower costs of the generically equivalent drug product or interchangeable biological product to the purchaser,” as noted in the legislative intent section of the law.
The new law is also expected to promote innovation and competitiveness in the market of biologic treatments. The policies are aligned with the principles of biologic substitution practiced by BIO, who announced in a press release that they will continue to advocate for patients’ right to full disclosure on the substitution process, as well as for physicians’ rights to be informed about the biologic medicine that is granted to their patients at the pharmacies.
“House Bill 751 enjoys the support of physicians across the country, patient groups, and both innovator biologic and biosimilar manufacturing companies,” said BIO’s president and CEO Jim Greenwood. “This bill includes communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record. By signing this bill into law, Governor Abbott has added Texas to a growing list of states that allow retail pharmacies to substitute interchangeable biologic medicines.”
BIO and THBI expressed their support for the legislation and gratitude to Governor Abbott. “Texas is a leader in biotech innovation, and now Governor Abbott has positioned our state as a leader in adopting policies that will allow patients access to safe and effective therapies when the first interchangeable biologics are approved by the FDA,” stated THBI’s president and CEO Thomas Kowalski. “Furthermore, these policies will provide patients with more opportunities to address their unmet medical needs, particularly severely ill patients who rely on cutting-edge medical treatments.”
The FDA recently approved the commercialization of the first biosimilar product, and the agency is committed to examining the safety and effectiveness of interchangeable biologic products. These medicines are manufactured from living cells by programming a particular cell line to produce a desired therapeutic substance in a highly controlled sterile environment, instead of being chemically synthesized.
“Interchangeable biologics are not generics. Even slight changes to a biologic drug can change its properties entirely,” explained Greenwood. “Unlike conventional generic medicines, interchangeable biologics are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same. Those suggesting interchangeable biologics and generics are the same are wrong.”
Despite the fact that the FDA is planning on approving applications this year for interchangeable biosimilar products and both BIO and THBI are supporting the new treatments, there are also opinions against it. Last year scientists at University of Texas MD Anderson Cancer Center expressed their concerns about the introduction of biosimilars into the market. Since biosimilars are analogous to generic versions of a patented therapeutic compound, but they are made by or derived from living organisms, Leonard Zwelling, MD, MBA, at MD Anderson stated that “it’s not quite like synthesizing something in a test tube.”