Generic drugmakers appear to be winning in the showdown with biologics makers over state legislation that would limit the automatic substitution of future biosimilars.

Colorado, Florida and Indiana are the latest states to shoot down a bill that would require notification and recordkeeping if a pharmacy substitutes a biosimilar for the prescribed biologic. The legislation was modeled on principles the Biotechnology Industry Organization (BIO) has identified as core safeguards for patients.

Initially, it looked like Florida was going to side with BIO on the safety issues. Last month, BIO praised the Florida Senate Committee on Health Policy for passing a bill that included the five safeguards:

limited substitution for biosimilars approved as interchangeable;

physician's right to prevent substitution;

physician notification of a substitution;

patient notification of the substitution;

required recordkeeping of the substitution.

But the biosimilar bill Florida lawmakers sent to the governor Friday was missing the safeguards BIO and some patient advocacy groups consider crucial. As a result, the Generic Pharmaceutical Association (GPhA) hailed the Florida bill as a victory for access, adding that notification and limits on substitution would have a chilling effect on biosimilars, which the trade group tends to equate with generics.

BIO, on the other hand, continues to stress that biosimilars are not generics; thus, safeguards are needed. Patients and physicians managing chronic conditions generally know which biologics work best in their unique circumstances, the organization said. Requiring notification "allows everyone involved the opportunity to discuss past treatment experiences so that any possible negative issues can be better understood and avoided," BIO added.

Congress gave the FDA the authority to approve both biosimilars and interchangeable biologics in 2010 as part of the Affordable Care Act, but whether, and how, pharmacy substitution is allowed is up to state law. (See BioWorld Today, Jan. 29, 2013.)

In March, Virginia was the first state to pass a law limiting biosimilar substitution at the pharmacy and setting up notification requirements. At the time, GPha called the law, which enjoyed unanimous support in the Virginia General Assembly, pre-emptive and said it had burdensome administrative red tape. The only good GPhA saw in the law was a 2015 sunset clause on prescriber notification. (See BioWorld Today, March 22, 2013.)

Since then, Utah and North Dakota have passed biosimilar bills containing some of BIO's recommended safeguards. Like Virginia, Utah included a sunset clause, "which most experts believe will render the restrictive sections moot before biosimilars come to market," according to GPhA.

As for the other states, the Indiana Legislature declined to pass a biosimilar bill before adjourning last month, and Colorado lawmakers are expected to conclude their session this week with the Senate refusing to take action on a biosimilar bill passed by the House, GPhA said.

Arizona, Maryland, Mississippi, Nevada and Washington state also have declined to pass BIO's model legislation. The measure is under consideration in California, Illinois, Massachusetts, Oregon, Pennsylvania and Texas, and the Arkansas General Assembly has referred it to a study committee.

Following the passage of the Virginia law, GPhA President and CEO Ralph Neas said states shouldn't act on such legislation until after the FDA issues guidance on interchangeable biologics.

In the U.S., a biosimilar must be "highly similar" to the reference biologic with no "clinically meaningful differences" in terms of safety, purity and potency, but it can have minor differences in clinically inactive components. An interchangeable biologic is expected to produce the same clinical results as the reference drug in any given patient. The risk, in terms of safety or diminished efficacy, of switching between an interchangeable and reference biologic must not be greater than from consistent use of the reference product.

While the FDA has yet to draft guidance on interchangeability, it anticipates that drugmakers, who have expressed a lot of interest in interchangeable biologics, would have to demonstrate biosimilarity first and then show sameness through switching trials with the reference drug, Rachel Sherman, director of the Office of Medical Policy at the FDA's drug center, said in an interview for the BioWorld Data report, The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies.

Although it's been more than a year since the FDA issued its draft guidance on demonstrating similarity, no drugmaker has submitted a 351(k) application for a biosimilar approval yet. But it may not be long before the agency gets the first one. (See BioWorld Today, Feb. 10, 2012.)

As of Tuesday, the FDA had received 56 requests for initial meetings to discuss biosimilar development programs involving 12 different reference products. So far, it has held 38 initial meetings with sponsors. Subsequently, many of those sponsors have moved their candidates into the development phase and are now requesting biosimilar product development (BPD) meetings, Lisa Kubaska, a spokeswoman for the FDA's drug center, told BioWorld Today. The agency is now holding BPD meetings and providing written advice for ongoing biosimilar development programs.

To date, the FDA has received 17 investigational new drug (IND) applications for biosimilars and several others are proceeding under a pre-IND, Kubaska said.

CER Projects Funded

The Patient-Centered Outcomes Research Institute approved 51 new awards, totaling $88.6 million over three years, to fund comparative clinical effectiveness research (CER) projects that fall under the first four areas of its research agenda.

The awards, approved Monday, will fund studies of how to best care for patients with kidney disease, certain cancers, obesity, asthma, diabetes and various mental health conditions. Other projects will examine ways to support patient decisionmaking, reduce some health disparities and improve health care delivery systems.

Editor's note: For a copy of BioWorld's new biosimilars report, please contact the BioWorld Data account managers for exclusive introductory pricing at (800) 477-6307.