COVID-19 has affected the pace of clinical trials, and the FDA’s most recent notice has been that there will be no “near-term” affect on approvals, said Leslie Fish, RPh, PharmD, who co-presented with Jeffrey Casberg, MS, RPh, in Tuesday’s session, "Drug Pipeline: Traditional Pharmaceuticals and Bisoimilars," at AMCP eLearning Days, which replaced the annual meeting of the Academy of Managed Care Pharmacy.
The year 2020 has already seen 4 biosimilar launches in the United States, and those could be augmented by several more, although the coronavirus disease 2019 (COVID-19) pandemic has introduced a wild card to the mix, said presenters at the American Academy of Managed Care Pharmacy eLearning Days virtual meeting.
But the pipeline from 2021 to 2025 is stocked with at least 5 approved biosimilars to adalimumab, and potentially 4 others, all of which could conceivably launch in 2023, and 14 other potential biosmilar products, which could make the next several years a very active growth time for the US biosimilar space, the presenters said.
The pace of clinical trials has also been affected, and with regard to approvals, the FDA’s most recent notice has been that there will be no “near-term” affect on these, said Leslie Fish, RPh, PharmD, who co-presented with Jeffrey Casberg, MS, RPh, in Tuesday’s session, "Drug Pipeline: Traditional Pharmaceuticals and Bisoimilars." Both are experts on the pharmaceutical pipeline with IPD Analytics.
One thing that could happen is that any delays caused by COVID-19 in 2020 could lead to a slew of backlogged approvals or launches in 2021, Fish said.
A lot of companies have stated that they are going to slow their existing studies or hold up new studies of various agents, because they’re now working on COVID-19 therapies or vaccines, she added.
The Biosimilar Launch Pad for 2020
There could be multiple biosimilar agents reaching the market in the oncology space for the remainder of 2020, Fish and Casberg said. One of those drugs is HSP-130, a pegfilgrastim biosimilar that Hospira and Pfizer intend to launch against Amgen’s Neulasta originator drug. However, HSP-130, expected to launch this June, would join other biosimilars already on the market, including Ziextenzo, Udenyca, and Fulphila.
An additional drug in this class is Rolontis (eflapegrastim). The FDA accepted the application for this investigational granulocyte-colony stimulating factor analogue in December of 2019. Rolontis is under development by Hanmi Pharma and Spectrum and is targeted for an October launch.
Another biosimilar that could debut this year is a bevacizumab copy (SB8) that Samsung Bioepis and Merck hope to bring to the US market in September, according to Casberg and Fish. There are 2 bevacizumab biosimilars on the market currently, Mvasi and Zirabev, which were introduced last year. The reference product is Avastin.
There is one other bevacizumab biosimilar candidate, Bmab-100, which is under development by Biocon. This also has the potential to augment the number of biosimilar bevacizumabs available to providers, Fish said.
Lastly in the oncology class of emerging biosimilars is a rituximab biosimilar, ABP 798, the product of an Amgen/Allergan partnership, with a debut scheduled for somewhere in the fourth quarter of this year. It would go up against 2 biosimilars already launched: Truxima by Celltrion and Ruxience by Pfizer. The reference product is Rituxan by Biogen and Genentech.
“With this many biosimilars on the market, and available, there will be a decrease in costs. This decrease in cost will be seen in increasing rebates and better contracting in both the branded and biosimilar space,” Fish said.
Loose Ends in Patent Litigation
Casberg said that eyes have been following the attempts by Sandoz to bring an etanercept biosimilar (Erelzi) to market. That issue was held up in court over patent litigation with originator manufacturer Amgen. “We’d been waiting for an Amgen versus Sandoz decision for quite a while. Turns out, Amgen prevailed, and we likely will not see an Enbrel biosimilar until 2029,” Casberg said. “There is still 1 pending court case that could change that, but odds are in favor of Amgen keeping protection for Enbrel through 2028/2029.”
There are 2 infliximab biosimilars on the market currently, Inflectra and Renflexis, and a third, Avsola (Amgen) will likely launched this year, Casberg said. Avsola was approved in December of 2019. “There are a couple other biosimilar infliximabs coming down the road,” he said. “Those won’t be available for another year or more.”
Hopes for an adalimumab biosimilar to AbbVie’s blockbuster Humira product had been on hold owing to patent litigation. Much of that legal activity has subsided, Casberg said, resulting in individual patent settlements with 9 potential competitors, each with an agreement to launch at some point in 2023. “So, 2023 will be a big year for biosimilar Humira,” he said. Of the 9 products for which settlements have been hammered out, 5 are approved by the FDA.
From 2021 to 2025, up to 14 additional biosimilars could be launched. These include biosimilars for ranibizumab, aflibercept, eculizumab, ustekinumab, cetuximab, omalizumab, botulinum toxin, natalizumab, abatacept, certolizumab pegol, darbepoetin alpha, golimumab, palivizumab, and ado-trastuzumab emtansine, Casberg said.
“There are quite a few bigger products in the works in coming years,” he said.
Novel drug approvals by the FDA have been on the uptick in recent years, Casberg noted. There were 48 last year and a record 59 in 2018. “This year with COVID-19, we’ll have to see if that impacts approvals,” he added.
As for launches thus far in 2020, 3 trastuzumab biosimilars have reached the market: Ontruzant, Herzuma, and Trazimera. Also, Pfizer launched its rituximab biosimilar, Ruxience, in January. The FDA has approved 26 biosimilars thus far, and of those,17 have been launched.