by Amanda Conschafter, blog editor
It’s time for clarity about the prescribing information that accompanies biosimilar medications, the U.S. House Doctors Caucus told the FDA in a Dec. 21, 2015 letter. What’s more, signers of the letter argue, the FDA should “solicit and consider” physician viewpoints when crafting the long-anticipated regulatory guidance.
The House Doctors Caucus includes 18 medical providers who also serve in Congress, using their medical expertise to shape health care policy. Rep. Brad Wenstrup (R-Ohio), a caucus member and a physician for more than 25 years, explained that biosimilars offered options for expanding treatment and reducing health care costs – but only if “physicians feel comfortable prescribing them and patients feel safe taking them.” Rep. Wenstrup signed the letter along with 11 other caucus members.
One way for the FDA to instill that confidence is to provide clear guidance on prescribing information, or drug labels. The letter acknowledges widespread support among physicians and patient advocacy organizations for prescribing information to:
- Identify the medication as a biosimilar
- Specify whether it has been approved by the FDA as interchangeable with its biological reference product.
Signatories noted that the label for FDA’s first approved biosimilar did not include this information.
“It can often be challenging and time consuming to find an effective treatment for many of the diseases that are treated by biologics,” Rep. Wenstrup noted. He added, “Unlike generics, biosimilars are not identical to the biologic drug. Therefore, it is essential for providers to be able trust the product descriptions….”
Another way to instill physicians’ confidence is by incorporating their input into the FDA’s process. “We believe patient and provider confidence will be enhanced if they have a voice in the development of key policies,” the letter notes. The letter also references a 2015 House Doctors Caucus roundtable where participants expressed unified concern about unresolved regulatory issues such as labeling.
The caucus isn’t the only group asking for a more robust biosimilars conversation among physicians, regulators and legislators. On January 6, a group of 23 patient organizations submitted a letter to the House Energy and Commerce Committee asking for hearings on patient safety and biosimilar medications. Signatories, which included the Alliance for Patient Access, requested “greater transparency.” They also noted the desire to see guidance “issued and finalized with full input from those who will take and prescribe biosimilars.”
For more on biosimilar labeling, watch AfPA’s “What Physicians Need to Know to Safely Prescribe Biosimilars.”