California Senate gives nod to biosimilar interchangeable bill
This article was originally published in SRA
Amgen's and Genentech's lobbying paid off on 4 September when senators from the US biotech giants' home state of California gave their blessing to legislation that would require pharmacists to notify prescribers within five days of the pharmacy substituting a biosimilar deemed interchangeable by the Food and Drug Administration for an innovator biologic.
The California Senate's late-day 30-2 vote came after the state's Assembly on 26 August overwhelmingly adopted the bill, known as SB 5981.
The legislation is awaiting the signature of Governor Jerry Brown (Democrat).
Under the bill, pharmacists must notify the patient at the time a substitution is made and, as in the case of small molecules, the pharmacy would be prohibited from switching a biosimilar if the prescriber indicates "Do not substitute" on the prescription.
Backers of the bill also include the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), BayBio, BIOCOM, California Healthcare Institute, Silicon Valley Leadership Group and TechNET. Supporters insist that putting the legislation in place would ensure incentives are maintained for innovators and promote competition for biologics.
SB 598 opponents, however, which include the Generic Pharmaceutical Association (GPhA) and many of California's health plans, such as CalPERS, argue the bill would create unnecessary barriers between patients and the lower-cost biosimilars – reducing potential savings for consumers, the government and the private sector – and would pre-empt the FDA's guidance.
The FDA has yet to approve any biosimilar for the US market. It in the midst of finalizing its biosimilar guidances it released last year in draft form2.
FDA spokeswoman Dr Lisa Kubaska told Scrip Intelligence, a Scrip Regulatory Affairs sister publication, that the agency does not have a position on California's bill or any other state biosimilar legislation. In a statement, the FDA noted that Congress "deliberately set a very high bar" for approval of biosimilars, with makers of those products required to demonstrate their medicines are highly similar to the reference product and differ in no clinically meaningful way in terms of its safety, purity and potency.
In fact, the FDA pointed out, only "minor differences" in clinically inactive components are allowed in biosimilars.
A manufacturer that seeks to gain the interchangeable designation must show the biosimilar would be likely to produce the same clinical result as the innovator's medicine in any given patient.
In addition, if a biosimilar is given more than once to a patient – as many biologics are – the manufacturer must also demonstrate the risk in safety or reduced effectiveness of alternating or switching between the biosimilar and the reference drug is not greater than using the original biologic.
The FDA also emphasized, however, that the law that established the regulatory pathway for biosimilars, the Biologics Price Competition and Innovation Act, which was passed by Congress in March 2010 as part of the Affordable Care Act, "expressly states" an interchangeable biosimilar may be substituted for the reference product "without the intervention" of the healthcare provider who prescribed the innovator biologic.
"Substitutability helped spur the growth of the generic drug industry at an earlier time and is similarly essential to help foster competition in the biologic drug market," the FDA said. "Ultimately, such competition will spur innovation, improve consumer choice and drive down medical costs."
The high standards for approval of biosimilar and interchangeable products, the FDA said, "mean that patients and healthcare professionals can be assured that, when these products go to market, they will meet the standards of safety, efficacy and high quality that everyone expects and counts on."
"Efforts to undermine trust in these products are worrisome and represent a disservice to patients who could benefit from these lower cost treatments," the FDA said.
But Actavis president and CEO Paul Bisaro, whose firm backed SB 598 – breaking from the majority of the generic drug community – argued the California bill would "serve to increase confidence in biosimilar products among patients, physicians and pharmacists, thereby enhancing their acceptance and accelerating the savings they will produce."
"SB 598 is timely legislation that provides a balanced framework governing the use of biosimilars and gives doctors and patients more and better choices," insisted Joseph Panetta, president and CEO of BIOCOM, a Southern California trade group representing life sciences companies.
BIO president and CEO Jim Greenwood called on Governor Brown to swiftly sign SB 598.
But GPhA president and CEO Ralph Neas pleaded with the state chief to veto the legislation "for the sake of California patients, the California budget and California taxpayers."
CalPERS, which provides retirement and health benefits to more than 1.6 million public employees and retirees and their families and more than 3,000 employers, said the bill would impose "unnecessary physician notification requirements on pharmacists," which the organization said could potentially reduce the number of prescriptions substituted with biosimilars.
CalPERS said if it is unable to realize the "full savings" from interchangeable biosimilar products, it may "ultimately be forced to raise prescription drug co-payments or health insurance premiums, shifting event more increasingly unaffordable health care costs onto our members and their families."
References
1. http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201320140SB598
2. US FDA issues much-awaited draft guidelines on developing biosimilars, Scrip Regulatory Affairs, 10 February 2012