MPA | Pharmacy News

by Ryan Chandanais, M.S., emerging therapeutics analyst, Diplomat Specialty Pharmacy

In 2015, the specialty drug pipeline is expected to continue to produce valuable new treatments for patients across a variety of disease states. The oncology and rare disease pipelines remain particularly strong, with several approvals expected in each area. Chronic hepatitis C (CHC) still has a few promising drugs in development, but the time of greatest innovation in that area may have already peaked. Biosimilar developments will be interesting to follow as well. We’ve seen only the tip of the iceberg regarding biosimilars, with the recent Food and Drug Administration (FDA) approval of the Neupogen® biosimilar, Zarxio™ (filgrastim-sndz). The issue of increasing cost of drugs and payors’ ability to sustain those costs is certainly not going away and will only intensify as additional high-cost drugs become available. The percentage of drugs approved that have earned special FDA designations during their development is expected to remain high as well.

In the remainder of 2015, oncology is forecasted to see approvals for approximately seven or eight new agents over the course of the year, along with some significant expanded indications for a few currently available therapies. Rare disease drugs are estimated to gain a total of about five or six new approvals for diseases, including cystic fibrosis, Duchenne muscular dystrophy, hemophilia, von Willebrand disease, hypophosphatasia and lysosomal lipase deficiency. Immunology is expected to see relatively few approvals. However, additional agents in the interleukin-17 (IL-17) class of drugs, similar to Cosentyx® (secukinumab) such as brodalumab, ixekizumab and guselkumab are expected to have a significant impact on the psoriasis market, but probably not until 2016 or later.

Biosimilars will continue to be a developing area of the pipeline. Zarxio™, the first FDA-approved biosimilar, earned the agency’s stamp of approval in March 2015. However, the product has not yet launched due to legal issues. Legal challenges will be a concern for other biosimilars in the pipeline as well. Other factors, including uncertainty surrounding biosimilar regulations in the U.S., questions of interchangeability with the brand name reference products, and patient and prescriber comfort level, make it difficult to determine the impact these agents will have or when they will launch. Due to the number of highly prescribed biologics with recently expired or soon-to-be expiring patents, biosimilars will be worth watching in 2015 and beyond.

Table 1. Expected FDA Decisions for the Remainder of 2015

Second Quarter 2015

Raltegravir (Isentress®) + Lamivudine (Epivir®) – MERCK

  • HIV (new combination)
  • Possible approval in the second quarter

Sirolimus (Rapamune®) – PFIZER

  • Lymphangioleiomyomatosis (LAM) (expanded indication)
  • June 15, 2015

Drisapersen – PROSENSA

  • Duchenne muscular dystrophy
  • June 30, 2015

Asfotase alfa – ALEXION

  • Hypophosphatasia
  • June 30, 2015

Third Quarter 2015

Lumacaftor – VERTEX

  • Cystic fibrosis
  • July 5, 2015

Gefitinib (Iressa™) – ASTRAZENECA

  • Non-small cell lung cancer (attempting to re-acquire approval)
  • July 2015


  • Hypercholesterolemia
  • July 24, 2015

Trabectedin (Yondelis®) – PHARMAMAR

  • Soft tissue sarcoma
  • Aug. 3, 2015

Cobimetinib – EXELIXIS

  • Melanoma
  • Aug. 11, 2015

Evolocumab – AMGEN

  • Hypercholesterolemia
  • Aug. 27, 2015

Obeticholic acid – INTERCEPT

  • Primary biliary cirrhosis
  • Aug. 31, 2015


  • Eosinophilic asthma
  • Sept. 5, 2015

Sebelipase alfa – SYNAGEVA

  • Lysosomal acid lipase deficiency
  • Sept. 8, 2015

Daclatasvir + Sofosbuvir – BRISTOL-MYERS SQUIBB, GILEAD

  • Hepatitis C, genotype 3
  • Sept. 15, 2015

Filgrastim (Neupogen® biosimilar) – APOTEX

  • Same indications as reference product
  • Mid-to-late 2015

Infliximab (Remicade® biosimilar) – CELLTRION

  • Same indications as reference product
  • Possible approval in the third quarter

Fourth Quarter 2015


  • Hemophilia A
  • Oct. 1, 2015

Pembrolizumab (Keytruda®) – MERCK

  • Non-small cell lung cancer (expanded indication)
  • Oct. 19, 2015 (likely early approval)

Vonicog alfa (BAX 111) – BAXTER

  • Von Willebrand Disease
  • Oct. 22, 2015

Selexipag – ACTELION

  • Pulmonary arterial hypertension
  • Oct. 23, 2015

Viekira Pak™ – ABBVIE

  • Hepatitis C, genotype 4 (expanded indication)
  • Oct. 24, 2015

Talimogene Laherparepvec – AMGEN

  • Melanoma
  • Oct. 27, 2015

Nivolumab (Opdivo®) – BRISTOL-MYERS SQUIBB

  • Melanoma, first-line treatment (expanded indication)
  • Oct. 27, 2015 (likely early approval)

Tofacitinib (Xeljanz®) – PFIZER

  • Psoriasis (expanded indication)
  • Oct. 31, 2015

Epoetin alfa (Epogen®, Procrit® biosimilar) – HOSPIRA

  • Anemia
  • October 2015

Tenofovir alafenamide – GILEAD

  • HIV
  • Nov. 6, 2015

Carfilzomib (Kyprolis®) – AMGEN

  • Multiple myeloma (expanded indication)
  • Nov. 27, 2015


  • Colorectal cancer
  • Dec. 9, 2015 (possible early approval)

Telotristat Etiprate – LEXICON

  • Carcinoid syndrome
  • Late 2015

Adalimumab (Humira®) – ABBVIE

  • Hidradenitis suppurativa (expanded indication)
  • Late 2015

Binimetinib – ARRAY

  • Melanoma
  • Late 2015



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