High-Impact Brand and Generic Drugs in the Late-Stage Pipeline

In a presentation at AMCP 2021, Jeffrey Casberg, PharmD, and Leslie Fish, PharmD, both vice presidents of pharmacy at IPD Analytics, provided a comprehensive review of the high-impact brand, generic, and biosimilar drugs that are likely to emerge from the pharmaceutical pipeline in the coming year.

The presenters also discussed legal matters that are affecting generic and biosimilar launches, including patent barriers and the need to launch at risk, as well as settlement agreements that can delay launch of generics. 

According to their analysis, 53 new molecular entities in biologics were approved in 2020, fewer than expected. Dr. Fish said that the COVID-19 pandemic is still having negative effects on medication approvals in the U.S. Only 20 medications had gone through the FDA Advisory Committee meeting process in 2020. Due to the pandemic, Advisory Committee meetings were not held from March to June 2020.

Additionally, according to Dr. Fish, the pandemic has resulted in study delays relating to the inability to gather patient data, the inability to physically assess patients and delayed or cancelled manufacturing plant inspections.

They also discussed several important agents for which loss of exclusivity is pending. These included nebivolol, with sales of $1.1 billion, which is due to go off patent in September of this year. Dabigatran, which had sales of $607 million, will lose patent protection in the fourth quarter of 2021. These two products may have at least 10 potential generic entrants, according to Dr. Fish.

Another significant product facing generic competition this year will be octreotide. With sales of $1.68 billion, Dr. Casberg believed generic octreotide will face stiff competition from other brands in the drug category.

The smoking cessation product varenicline (Chantix) will face loss of exclusivity in the first half of 2021. Sales of $1.2 billion will be fought over by four generic rivals. The current WAC price for the brand is $1,300 for a 12-week treatment regimen. Dr. Casberg believes that heavy generic competition will drive down that price considerably.

Generic products will be newly marketed in the coming 18 months in virtually every therapeutic area. Branded agents face competition from new 505(b)2 products as well as biosimilars. New 505(b)2 products pending approval from the FDA include competition for such familiar drugs as budesonide, leuprolide, naloxone, and risperidone. The 505(b)2 application for budesonide is for an oral suspension by Takeda, which is seeking an indication for eosinophilic esophagitis (a condition for which no current FDA-approved therapy exists).

Oyster Point has filed a 505(b)2 application for varenicline in nasal spray form, to be used to treat dry eye. This nicotinic acetylcholine receptor agonist stimulates a facial nerve to trigger the production of tears.

Dr. Casberg noted that several new bevacizumab biosimilars will be launched in 2021, including those by Samsung Bioepis, Bio-Thera Solutions, Centus Biotherapeutics, and Biocon (including their respective partners). In addition, he forecasted perhaps four new pegfilgrastim biosimilars to be launched in 2021, and potentially two additional filgrastim biosimilars to launch this year.

Companies offering the high-dose concentration of adalimumab may launch their products as early as August 2022—before the January 2023 scheduled launch of Amgen’s biosimilar Amjevita.

A biosimilar of ranibizumab (SB11) has a scheduled FDA decision date of September 2021, and there are three additional ranibizumab biosimilars in phase three studies. Importantly, Outlook Therapeutics may have an approval for its ophthalmic formulation of bevacizumab in 2022.

Mylan is hoping its insulin aspart biosimilar application finds favor with the FDA in 2021. Sanofi has conducted interchangeability studies on its own insulin aspart biosimilar, as has Mylan on its insulin glargine biosimilar Semglee. Two other companies have publicly disclosed that they conducted the switching studies needed to seek interchangeability designations: Boehringer Ingelheim for Cyltezo and Nichi-Iko for its investigational biosimilar to Remicade.

Casberg J, Fish L. Drug Pipeline: Traditional Pharmaceuticals and Biosimilars. Presentation F8. Presented at AMCP 2021; April 12-16, 2021.