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.

Next: Recently approved specialty medications

Recently approved specialty medications

Specialty drug markets are maturing for treating hemophilia B, renal cell carcinoma, hepatitis C, psoriasis, and multiple sclerosis (MS), Tharaldson said.

On March 13, Kisqali (ribociclib) once-daily oral CDK-4 and -6-inhibiting breast cancer drug was approved by the FDA for first-line treatment of patients with hormone-receptor-positive (HR+), HER2-negative breast cancer who are undergoing aromatase inhibitor therapy.

Other first-quarter 2017 specialty drug approvals included Emflaza (deflazacort for muscular dystrophy, Siliq (brodalumab), which is a subcutaneously administered treatment for psoriasis, and Xermelo (telotristat) for carcinoid syndrome diarrhea.

Specialty drug pipeline

The near-future specialty drug pipeline for 2017-2018 includes new medications for inflammatory conditions, MS, cancer, HIV, hepatitis C, asthma and allergy, nonalcoholic steatohepatitis, Tardive Dyskinesia, osteoporosis, and orphan drugs, Tharaldson said. More nascent development of new agents for Alzheimer’s disease are also underway.

Drugs for inflammatory conditions that are in development include biosimilar competitors for tumor necrosis factor (TNF) inhibitors and other biologics, as well as new injectable biologics and expanded indications for existing drugs. Olumiant (Baricitinib) for rheumatoid arthritis (RA) is anticipated to see FDA approval next month, as is  Renflexis (infliximab biosimilar), an IV-administered agent for treating RA and psoriasis.

Other RA-indication drugs expected to see approval in 2017 include adalimumab (BI 695501), sirukumab, and sarilumab.

Baricitinib is a once-daily oral JAK inhibitor for RA slated for approval April 19, 2017, Tharaldson noted.

“Sirukumab is a subcutaneous injection every two or four weeks,” she added. “It is an IL-6 inhibitor and approval is expected on September 23, 2017.”

FDA approval for Janssen’s guselkumab, a psoriasis treatment, is expected in July 2017. Guselkumab is an IL-23 inhibitor; it is injected subcutaneously every eight weeks after induction.

Tildrakizumab, another subcutaneously injected psoriasis medication, is administered every 12 weeks after induction and is expected to see FDA approval in late 2017 or early 2018, Tharaldson said.

The MS pipeline involves five medications anticipated to receive FDA approval by 2019, including the generic immunosuppressant Copaxone (glatiramer acetate injection) for reducing flare frequency among patients with relapsing-remitting MS (RMMS), which is expected to see approval in the second half of 2017, Tharaldson said.

Ocrevus (ocrelizumab) was approved for treating aggressive MS March 28, she noted. Ocrelizumab blocks immune B cells, whereas other MS drugs target immune T cells. The FDA approved ocrelizumab for patients with primary-progressive MS. It is the first approval for this form of MS.