Semglee (insulin glargine) will be the first test of the FDA's interchangeability concept for biosimilars, but Viatris aims to grow its biosimilar revenues with multiple products.
Not quite a year old, Viatris, the company formed by the merger of Mylan and Pfizer’s Upjohn division, is banking heavily on its biosimilars portfolio and pipeline, which contain approved and marketed products as well as various product candidates in clinical development or under regulatory review.
The Canonsburg, Pennsylvania, company made headlines in July 2021 when the FDA upgraded its insulin glargine product (Semglee) to biosimilar and interchangeable status, meaning pharmacists could dispense Semglee without first obtaining physician clearance.
The product will be the first test of the FDA’s interchangeable designation, and biosimilar stakeholders will be watching to see whether interchangeability serves to boost uptake for Semglee, which was first approved in June 2020 as a nonbiosimilar rival to Lantus.
“Semglee is not the only [product] in our pipeline this quarter. With regard to our biosimilar and complex products pipeline, we're making steady progress across multiple programs,” Michael Goettler, CEO, said in an investor presentation this week.
In the second quarter 2021 earnings conference, Viatris officials said they also have confidence in their aflibercept product candidate, which they hope to get through the FDA review process ahead of rival companies.
“There are a number of competitors going through this. We’re leading right now. We’re the first ones to finish a [phase 3] clinical trial,” Goettler said.
Viatris reported $333 million in combined biosimilar and complex generics sales for the quarter just ended, down 5% from $351 in the comparable 2020 quarter; however, biosimilar sales were up 40%. The overall sales decline in this combined category was attributed to generic drug competition.
The company, formed in November 2020, reported total sales of $4.56 billion, up from $4.35 billion in the (adjusted) year-ago quarter, a 5% improvement.
Viatris also reported complex generic and biosimilar sales by global region. In North America and the European Union, biosimilar sales for the quarter just ended were $309 million. The company is far less active in terms of biosimilar and complex generic sales in South and Central America, Africa, the Middle East, and Russia. The company reported second quarter 2021 sales of $14 million for these zones.
In Australia, Japan, and New Zealand, biosimilar and complex generic sales were $10 million, up 16%; and, so far, Viatris’ sales of biosimilars have not penetrated China.
Viatris has regulatory approvals for etanercept (Nepexto) and adalimumab (Hulio) biosimilars. In February 2021, Viatris launched Hulio in Canada and Japan. Hulio was launched in the European Union in 2018. The company’s etanercept product was launched in the European Union in 2020. Viatris is currently seeking regulatory approval for bevacizumab and insulin aspart biosimilar candidates.
Viatris has another insulin glargine product in preclinical development (referencing Toujeo; Sanofi), as well as an onabotulinumtoxin biosimilar (referencing Botox) in preclinical stage development.
The aflibercept biosimilar candidate is on the cusp of FDA regulatory submission, and this is scheduled for the fourth quarter of 2021, according to Rajiv Malik, president of Viatris.
For an article on expert views of the insulin market and biosimilars, click here.