FDA approvals for specialty drugs to pick up in 2017
The specialty drugs market is seeing increased competition and important advances in cancer and orphan drug development, including specialty generics and biosimilars, according to an update presented at the AMCP Managed Care & Specialty Pharmacy Annual Meeting in Denver.
Following December’s FDA approvals of the intravenous biosimilar Lartuvo (olaratumab) for soft tissue sarcomas and the oral ovarian cancer biosimilar Rubraca (rucaparib), biosimilar and other specialty drug approvals are expected to hasten in 2017. That’s according to Aimee Tharaldson, PharmD, senior clinical consultant in emerging therapeutics at Express Scripts in Woodbury, Minnesota, who presented the March 28 session, “Specialty Pharmaceuticals in Development.”
“Last year we saw a dip in FDA specialty drug approvals but this year we are going to rebound with about 30 pending approvals,” Tharaldson said.
With 73 patent expirations for biologic agents by 2021, biosimilars will begin to emerge as a larger market presence in the next several years, she noted.
New FDA biosimilars approvals over the next five years—including anticipated biosimilar approvals for the anti-cancer biologic agents Avastin (bevacizumab) and Herceptin (trastuzumab)—could represent a $46.2 billion market, Tharaldson noted.
“There is a lot of activity in this area,” Tharaldson said. “Biologics are really acting more like competing brands, coming in at perhaps a 15% discount” compared to brand-name biologics.
Pending approvals/patent expirations
FDA approvals are pending for biosimilars with indications for inflammatory conditions, anemia, neutropenia, and oral drugs for several types of cancer.
“A biosimilar for trastuzumab could be approved in September,” she said. “This would be the first cancer biosimilar approved by the FDA.”
The FDA has recently released key guidance documents for biosimilars, including guidance on interchangeability criteria and the naming of biosimilars. (The FDA announced in January 2017 that biosimilars will be named by their reference biologics’ generic names plus a four-letter suffix, such as “filgrastim-sndz” for Sandoz’s biosimilar Zarxio, for which the reference biologic is Neupogen—Amgen’s filgrastim, and infliximab-dyyb for Inflectra, Celltrion and Pfizer’s biosimilar for Remicade, Janssen’s infliximab.)
However, the new naming process faces “pushback” that will likely delay implementation, because of the time and expense involved in changing biosimilar agents’ names, she said.
Specialty medications are those requiring frequent dosing adjustments or intensive clinical monitoring, intensive patient training or compliance assistance, limited distribution, and special handling, Tharaldson explained. “They may only be available through specialty pharmacies,” she noted.
Patent protections for the biologics Lemtrada (alemtuzumab), a treatment for chronic lymphocytic leukemia and certain T-cell lymphomas) and Amevive (alefacept) expire this year. In 2018, patents for anti-autoimmune and anti-cancer biologics Humira (adalimumab), an immunosuppressant approved for psoriasis and other autoimmune disorders, Rituxan (rituximab), and Erbitux (cetuximab) will expire—opening those agents to biosimilar competition, she noted.