A Look at the Generic and Biosimilar Drug Pipeline

During a presentation at AMCP eLearning Days, Jeffrey Casberg, MS, RPh, and Leslie Fish, RPh, PharmD, both vice president of pharmacy at IPD Analytics, LLC, discussed potential generic and biosimilar drugs coming to market, including projected timelines and implications for managed care pharmacy.

To reduce drug approval time, the U.S. Food and Drug Administration (FDA) has changed policies that speed up medication approvals, including accelerated and expedited reviewers, shorter studies, and use of surrogate markers. However, this often means less data are available about clinical efficacy and side effects at launch and more post-marketing studies are required.

The speakers detailed notable brands losing exclusivity in the near future and what that means for the treatment landscape. In the HIV treatment landscape, Atripla® (efavirenz/emtricitabine/tenofovir disproxil fumarate) will lose exclusivity in September. There are four new potential entrants to the space in 2021 and two in 2029. Truvada® (emtricitabine, tenofovir disoproxil fumarate) will also lose exclusivity in September. A new potential entrant could come this year, with nine potential options in 2021.

In the oncology space, Afinitor® (everolimus) 2.5, 5, and 7.5 mg already have a generic on the market, with four potential other generics in the pipeline. Afinitor® (everolimus) 10 mg has an additional four potential generic options. Zortress® (everolimus) 0.25, 0.5, 0.75, and 1.0 mg have three potential generic options.

Byetta™ (exanitide), a glucagon-like peptide-1 treatment for type 2 diabetes, will lose exclusivity this year, with two potential generic entrants. Dalirsp® (roflumilast) is a phosphodiesterase-4 inhibitor for the treatment of chronic obstructive pulmonary disease that will lose exclusivity this year or in 2021. There are 12 potential new generic entrants. Chantix® (varenicline) for smoking cessation has a loss of exclusivity this year or in 2021, with six potential generic entrants available between this year and 2022.

In March, the approved marketing applications for the small subset of “biologic products” such as insulin and human growth hormone, which for complex historical reasons were previously approved by the FDA as drugs under the new drug application (NDA) process, were deemed to be biologics. A 505(b)(2) is an NDA that has some efficacy and safety information from the applicant but also relies on information that comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.

The speakers then discussed some notable 505(b)(2)s that are pending approval:

  • Rizaport® (rizatriptan benzoate) for migraine headache
  • Naloxone nasal spray 8 mg for opioid overdose
  • Trevyent® (treprostinil) for pulmonary arterial hypertension
  • Apomorphine, a dopamine receptor agonist for Parkinson’s disease
  • Celecoxib 56 mg/tramadol 44 mg tablet for severe pain

In addition, several biosimilars are expected to launch this year, including:

  • HSP-130 (pegfilgrastim) in June
  • SB8 (bevacizumab) in September
  • Rolontis (pegfilgrastim) in October
  • ABP 798 (rituximab) during the fourth quarter

There also appear to be 14 potential biosimilar agents that will launch in the next five years for ranibizumab (Lucentis®), eculizumab (Soliris®), ustekinumab (Stelara®), abatacept (Orencia®), golimumab (Simponi®), and more.

Presentation: Drug Pipeline: Traditional Pharmaceuticals and Biosimilars. AMCP eLearning Days, April 20-24.