Mylan on Biosimilars: "If We Don't Have a Product, We'll Go and Find It"

This week, drug maker Mylan held its annual Investor Day for 2018. The presentation provided an overview of the company’s pipeline, including updates on the progress of multiple biosimilars, where Mylan stands in the current marketplace, and what investors can expect this year.

During the presentation, Mylan president Rajiv Malik stressed the durability of the company, citing its broad portfolio of 7500 marketed products currently for sale in 165 countries, with no single product ever generating more than 4% of its total revenue. The approximate net worth of Mylan’s combined pipeline and products pending approval is $327 billion, and $100 billion of that belongs to biosimilars and insulins.

Malik explained, “Mylan’s commitment to biosimilars continues. We have been very diligent in selecting the portfolio, depending upon the technology, market needs, and what our partners could deliver. It’s essentially a partnership-driven model, and I think we’ve come a long way from where we started 10 years back. We continue to fine-tune this portfolio, we continue to prioritize and continue to look into market needs and what we may have to change, and we will continue to invest as we go along.”

In the past year, Mylan has made significant strides in the biosimilar sphere. In December 2017, its trastuzumab biosimilar (referencing Herceptin and developed with Biocon) was granted FDA approval, which notably made the drug not only the first Herceptin biosimilar to be approved in the United States, but also Mylan’s first US biosimilar approval. Recently, it has also been granted approval in both Brazil and Canada.

Other biosimilars currently in Mylan’s pipeline and their respective statuses include:

• Pegfilgrastim (referencing Neulasta), for which a Biologics License Application (BLA) and a European Marketing Authorization Application have been submitted

• Bevacizumab (referencing Avastin), currently in a phase 3 clinical trial
• Adalimumab (referencing Humira), currently in a phase 3 clinical trial
• Filgrastim (referencing Neupogen), in preclinical development
• Etanercept (referencing Enbrel), in process development
• Pertuzumab (referencing Perjeta), in cell line development

Mylan is developing each of these biosimilars with a number of respective partners, including Biocon, Momenta, and Revance.

During the presentation, Arnd Annweiler, PhD, head of global research and development, spoke about recent biosimilar molecule acquisitions, specifically darbepoetin alfa (referencing Aranesp) and adalimumab (referencing Humira) and how important acquisitions such as these are for the company.

Malik said, “While science is very important, and we continue to monitor it very closely, the progress we are making with various programs with the various markets and partners—markets come first. And when we realized that we would not be in time for Europe for market formation for our biosimilar to Humira, we had to make a call in favor of the [Fujifilm Kyowa Kirin] product, which we are very happy that we could find an opportunity to be in the market at the time of the market formation.”

Malik emphasized that “Nothing is wrong with the Biocon partnership—as you can see, we keep on adding—but market comes first. If we don’t have a product and the market needs it, we’ll go and find it. Rituximab for Europe is a good example, we didn’t have it in the portfolio for either Biocon or Momenta, but we could find an opportunity…we’ll continue to do this; go out and keep on looking if there are gaps.”

In closing the presentation, Annweiler suggested that Mylan is expecting positive news regarding the June 4, 2018 action date for its proposed pegfilgrastim biosimilar from the FDA. He noted that all FDA questions had been addressed, and once a decision is announced, Mylan is prepared to expand its submissions globally.