Biocon Reports Strong Quarter for Its Biosimilars Unit

Topping a productive period, Biocon said its total revenues for the fiscal first quarter came to $225.8 million, up 14% driven by growth in its biosimilars and generics business units, which the company said grew 19% and 16%, respectively.

Net profit was $20.4 million. The company’s research services business experienced flat revenue of $56.4 million, which the company attributed to a slowdown caused by the coronavirus disease 2019 (COVID-19) pandemic.

“It has been a breakthrough quarter for Biocon as we made a significant contribution to the global efforts aimed at addressing the pandemic through our innovative science,” the company said in a statement.

FDA Approvals

During the quarter, the company received FDA approval for its insulin glargine (Semglee), the third product resulting from its collaboration with Mylan to be approved in the United States.

Biocon partner Mylan, meanwhile, received FDA approval for a biosimilar adalimumab (Hulio), for which Biocon has a shared economic stake.

Biocon also received a certificate of Good Manufacturing Practice from the European Medicines Agency for its drug manufacturing facility at Biocon Park in Bengaluru, India.

Biosimilars revenue for the just-ended quarter was $92.5 million, up from $77.8 million in the comparable, year-ago quarter. Biocon estimated that the number of patients who used the company’s biosimilars totaled 2.9 million in the just-ended quarter.

Global Markets Growth

It said the growth reported for this business period was derived from strong sales across most of its global markets along with steady sales in the United States and Europe, “aided by a spillover of revenues from the previous quarter.”

The company said it anticipated further growth based on demand in Latin America and the Commonwealth of Independent States, which include 12 former Soviet republics (Russia, Armenia, Belarus, Kazakhastan, etc).

“We have started [fiscal year 2021] on a very strong note,” said Christiane Hamacher, CEO and managing director of Biocon Biologics India, the biosimilars arm of Biocon. She said sequential growth from the fourth quarter of the previous fiscal year to this quarter was 60%.

Among the company’s recent achievements was its deal with Voluntis to market the digital titration device Insulia for patients receiving basal insulin products. The company believes Insulia has strong potential to gain a business hold during the COVID-19 crisis because of the need for patients to be able to self-manage their care from their homes. Via Insulia, patient medication can also be monitored by health care workers remotely.

Biocon has 3 FDA-approved biosimilars. It hopes to launch an etanercept biosimilar in Europe later this year.

The company said its biosimilar pegfilgrastim (Fulphila), codeveloped with Mylan, has held onto its market share in the United States “despite increasingly competitive dynamics.” It did not disclose that market share. During the just-ended quarter, the product was launched in several European markets.

Ogivri, a trastuzumab biosimilar, is also a Biocon/Mylan collaboration that the company said has seen “a positive trend in market share” in the United States.

In the Pipeline

The company has a bevacizumab biosimilar candidate that is under FDA and EMA review currently.

In addition, the company is working with the FDA on a 351(k) application to bring a recombinant human insulin (rh-insulin) to the market as a biosimilar. Biocon also is working with Mylan on the development of a biosimilar insulin aspart.

“We target to have at least 8 of our biosimilars available in developed markets through our partner by the end of fiscal year 2022,” the company said in its statement. Those are trastuzumab, pegfilgrastim, adalimumab, bevacizumab, etanercept, insulin glargine, insulin aspart, and rh-insulin.”

Biocon has recently stated it intends to take its biosimilars unit public in the next few years.