Critics of the US Food and Drug Administration (FDA) have long pointed fingers at the agency's complex and arcane approval process as one of the main reasons for a lack of competition, and consequently, higher drug prices and costs.
But a look at EvaluatePharma's predictions for the top 10 best-selling drugs for 2018 turns that theory on its head (at least for the best sellers) as it shows that FDA is no longer as big of a road block as patents and litigation.
Take, for example, Abbvie's Humira (adalimumab), the expected frontrunner in 2018 and undisputed champ of sales in 2017 and 2016. FDA has already approved two biosimilar competitors - Boehringer Ingelheim's Cyltezo (adalimumab-adbm) and Amgen's Amjevita (adalimumab-atto) – both of which would already be marketed in the US if all the companies needed was FDA approval.
Instead, neither are likely to hit the US market anytime soon, and Amgen has agreed to delay its biosimilar's launch in the US until 31 January 2023.
And though Humira might seem like an outlier (since it's second only to Pfizer's cholesterol behemoth Lipitor in all-time sales), FDA has already approved competition for Enbrel (3rd on the list) with Erelzi (etanercept-szzs), which has yet to hit the US market and has patent protection through 2029; for Avastin (5th on the list) with Mvasi (bevacizumab-awwb), which may not come to market in the US until early 2019; and for Herceptin (7th on the list) with Ogivri (trastuzumab-dkst), which was just approved in December 2017, though the launch date remains unknown.
Remicade (8th on Evaluate's list), meanwhile, also has two biosimilar competitors approved by FDA, both of which have launched, but uptake has been modest, barely scraping 5% of the market. The only other biosimilar to launch is Zarxio (filgrastim-sndz), which was approved in 2015.
So were these delays between FDA approval and marketing to be expected when the US biosimilar approval pathway was created by the Biologics Price Competition and Innovation Act (BPCIA)?
Elaine Blais, head of the litigation department in Goodwin Procter's Boston office, told Focus: “I do think some delay was anticipated when the BPCIA was written. Though there is no 30 month stay for biosimilars, like we have with generics, the risk of a large damages award causes many biosimilars companies to wait for patent resolution before launching their products. This may be a problem that works itself out over time as patents are litigated during the 12 year regulatory exclusivity period thus allowing for a risk-free (or less risky) launch upon approval.”
In contrast to the US, the EU biosimilars market seems to be seeing speedier launches and faster uptake of biosimilars for competition in the top 10 list.
Remicade biosimilars now have 53% of EU market share when compared with their reference products, while Enbrel biosimilars see 29% market share and Rituxan (rituximab) biosimilars, which have yet to be approved in the US but are coming, have gained 13% of market share, according to Bernstein biotech analyst Ronny Gal.
Editor's note: Article updated 3/6/18 with a link to Evaluate's report and to reflect that both Remicade biosimilars and Zarxio are the only biosimilars to launch in the US.