Russia May Open the Spigot on Biosimilars

Russia has made significant investments in its generic and biosimilar drug development industry, and for Russia-based companies looking toward international markets for their products, Europe and emerging countries look more attractive than the United States, according to Roman Drai, MD, PhD, deputy director and head of clinical operations for Geropharm, a Russian pharmaceutical company based in Saint Petersburg.

The US market was interesting enough to lure Drai to the recent World Biosimilar Congress USA 2020 at the Festival of Biologics USA in San Diego, California; however, the difficulties of entering this market and the perceptions of biosimilars here have not tempted the company to consider incorporating US sales into its short-term strategy, he said.

“We understand that the US market doesn't perceive biosimilars as well as the European market. There’s quite a lot of lobbying from big pharmaceutical companies behind this. And we see this not only in the United States, but also in Russia,” Drai said.

Roughly 70 biosimilars have been approved in Europe, making that a much more mature market than the United States, where 26 biosimilars have been approved and 16 launched, Drai noted.

Geropharm Is Active in Asia and the Americas

Currently, Geropharm targets Latin America and the Far East for its products and does not do business with the United States. Large pharmaceutical companies in the United States have been accused of deliberately misleading physicians and the public on biosimilars in order to bias consumption toward originator products. That’s one obstacle with doing business in the United States, Drai said.

“They think that biosimilars couldn't be as safe and have the same efficacy as the innovative drug, and maybe 10, 15 years ago, that was the case…. Now, in 2020, the biopharmaceutical companies have had quite huge development,” he noted.

The FDA and the Federal Trade Commission have sought to step up their vigilance on this issue. They say the public has not been given the full story of how effective and safe biosimilars are compared with their reference products.

Geropharm has worked to bring insulin and peptide biosimilars to market. Drai said the marketing of “pseudo innovative drugs,” or follow-ons with only minor improvements or changes, is an obstacle to successful marketing that has damaged Geropharm’s efforts to launch a biosimilar insulin glargine in Russia.

Snagged by a Lantus Follow-on

The company launched an insulin glargine in July 2019 on the Russian market, but at the time, patients on the Lantus originator product by Sanofi were being switched to a gel formulation. Sixty-five percent made the switch, which complicated Geropharm’s insulin glargine promotion, Drai said.

“When we see that the patent is expiring, and we are going to launch a new biosimilar, we see that originator launch another product to the same market, and that agent is also very similar to the previous one, and they call it ‘best in class’ or ‘next in class.’ And of course, physicians would prefer innovative products rather than biosimilars to older drugs,” Drai explained.

However, the company has a breadth of biosimilar insulins, ranging for ultra—short-term acting to medium and long-term insulin, “so we can cover all of the Russian market, and not only the Russian market, but some other markets as well. We have quite good capacity to do this.”

Last year, Geropharm received marketing authorizations in Russia for 3 of its insulins, “and that’s why we started also thinking of going abroad, and we started from emerging markets—from Latin America to the Far East. We have a goal to go to the European market as well. But as for the US market, it’s quite tricky for us,” Drai said.

Keeping a Watch on the US Market

The United States market may improve in the near term, but it bears watching, Drai said.

In the United States, Drai has noticed an increase in biosimilar conferences, a rise in education efforts, and newly introduced legislation, which he says could improve public perception of biosimilars. He said the March 23 change in the biologics pathway for certain small-molecule drugs, including all insulin products, under the Biologics Price Competition and Innovation Act may open the door to more biosimilar competition.

“I think doing business with the United States would be more attractive if we see that these changes really work, because I saw that, maybe a couple years ago, there were some biosimilars that were FDA approved but not all of them launched. Let’s see what will happen in the future,” Drai said.

Under the Soviets, the pharmaceutical industry flourished, but the change in government and market structure caused that to disintegrate, Drai said. With government support, there has since been a revival and a heavy investment in generics and biosimilars, he said.

In Russia, they developed an initiative to support drug companies by developing more generics and biosimilars by 2020. This initiative was so successful that Russia extended the efforts to 2030, “and this Pharma 2030 effort will concentrate not only on generics and biosimilars, but on original drugs. I would say that we have really made a huge step forward, and now we are not only international leaders, but we’re also trying to adopt international strategies, Drai said.

Geropharm and other pharma companies in Russia are doing clinical trials in Europe. “I think that we have in our pipelines good candidates, which would be first in class or best in class. And let’s see…I think that by 2030 we will have some blockbusters as well, and so we will compete with Europe and the United States,” he said.

In its international efforts, and with a growing pipeline of biosimilar candidates, Geropharm hopes to partner with more pharmaceutical companies, especially the larger ones.

Drai noted, “In the future, in order to step into Europe or the United States, we understand that we have to have collaboration with bigger pharmaceutical companies. So, in the Russian market, we, of course, are also making some progress with this…but we still have to do more.”