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Will COVID-19 Clog Generics, Biologics Pipeline?

IPD Analytics experts discussed the impact of Covid-19 on the drug pipeline. The current pipeline launch schedule heavily features generics, biosimilars, and 505(B)(2) drugs. Leslie Fish, RPh, PharmD, of IPD Analytics stated that near-term launches would likely not be impacted, however, current or future clinical studies will likely be delayed to make room for Covid-19 vaccination efforts.


The drug pipeline for 2020 is heavy on generics, biosimilars and 505(b)(2) drugs that are slight variations of existing products. But whether those launches will be affected by the ongoing COVID-19 pandemic is a bit more difficult to predict, industry experts noted during an AMCP webinar.

A number of notable generic launches are expected in 2020, said Jeffrey Casberg, MS, RPh, and Leslie Fish, RPh, PharmD, who are both vice presidents of pharmacy for the research organization IPD Analytics.

Generics for emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead); dimethyl fumarate (Tecfidera, Biogen); dexlansoprazole (Dexilant, Takeda); and fingolimod (Gilenya, Novartis) could drive drug prices down significantly, Dr. Casberg said.

Six potential generic entrants are in the works for the smoking cessation medicine varenicline (Chantix, Pfizer), which is expected to lose patent exclusivity this year, Dr. Fish said. Payors are looking forward to lower-cost options for the widely used drug, with sales of $702 million, she noted.

Nine potential generics could hit the market for fesoterodine (Toviaz, Pfizer), an antispasmodic for the treatment of overactive bladder symptoms, which also is expected to lose patent exclusivity this year. A number of other generics and branded drugs are available to treat the condition, Dr. Fish noted, making this an area ripe for drug utilization management.

In the Pipeline

About a dozen notable 505(b)(2) drugs have been approved or have approvals pending, the speakers said. These include ethinyl estradiol-levonorgestrel (Twirla, Agile), a transdermal birth control system approved in February, and apomorphine (APL-130277, Sunovion), a sublingual dopamine receptor agonist for the acute, intermittent treatment of “off” episodes in patients with Parkinson’s disease, approved in May.

This year also should see a number of launches of biosimilars, the speakers predicted. This includes HSP-130 (Hospira/Pfizer) and Rolontis (Hanmi Pharma/Spectrum) for pegfilgrastim, expected between June and October; SB8 (Samsung Bioepis/Merck) for bevacizumab, expected in September; and ABP 798 (Amgen/Allergan) for rituximab, expected in the fourth quarter, Dr. Fish said. They’ll join six approved biosimilars for pegfilgrastim, three for bevacizumab and three for rituximab.

“We believe with this many biosimilars in the market, we will see decreased cost, but the decrease will be seen through increasing rebates and better contracting in both the brand and biosimilar space,” Dr. Fish said. The presenters also referenced a number of new branded products that have been approved or are expected to be approved this year. These include bempedoic acid (Nexletol, Esperion) and bempedoic acid-ezetimibe (Nexletol, Esperion), approved as a first-in-class adjunctive therapy for patients requiring additional cholesterol lowering beyond that seen with standard treatments, and inclisiran (Novartis), an experimental subcutaneous PCSK9 inhibitor expected to be approved in the fourth quarter.

Pandemic Pressures

The COVID-19 pandemic could affect new drug approvals, Dr. Fish said during a question-and-answer period. The FDA has been back and forth, saying there would or would not be delays, she noted. As of April 17, the agency announced that everything coming to near term, especially oncology and orphan medications, and those for serious diseases, will not be delayed, she said. However, several manufacturers have reported they were going to slow down or delay clinical studies because they are shifting gears to work on potential COVID-19 therapies. It’s also difficult now for study participants to get to their physicians for checkups or lab tests, Dr. Fish said. Combined, she said, these factors could result in a larger number of medications being approved in 2021.


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