Incheon, South Korea-based Celltrion’s chairman Jung Jin Seo announced at last week’s JP Morgan Healthcare Conference the company’s strategy for the next decade. In particular, he indicated plans to launch a biosimilar every year until 2030.
Biosimilars are generic versions of biologic drugs. Unlike traditional generic drugs, they are not exact copies, but are similar to their branded counterparts. As such, they undergo an approval process similar to a new drug.
Biosimilars are often encouraged by payers because the increased competition leads to lower-priced drugs. In July, the U.S. Food and Administration (FDA) rolled out its Biosimilars Action Plan. Then-FDA Commissioner Scott Gottlieb noted that less than 2% of Americans use biologics, but they account for 40% of total spending on prescription drugs. They also represented 70% of the growth in drug spending from 2010 to 2015. They are projected to be the fastest-growing segment of drug spending.
As a result, the FDA and U.S. payers, he noted, should make it a priority to reduce the costs of biologics. In a speech at the Brookings Institution at the time, Gottlieb said the Action Plan was designed to help “make the process for developing biosimilars more efficient.”
Although biosimilars have been well-accepted in Europe, their adoption in the U.S. has been much slower. Some of this is related to pharma legal efforts and lawsuits to delay the biosimilar competitors from entering the U.S. market.
The Biosimilars Action Plan involved 11 key actions. They included:
- Develop and implement new FDA review tools.
- Create information resources and development tools for sponsors.
- Enhance the Purple Book to include more data about approved biological products.
- Explore the possibility of data sharing agreements with foreign regulators.
- Establish a new Office of Therapeutic Biologics and Biosimilars (OTBB).
- Expand on the agency’s Biosimilar Education and Outreach Campaign.
- Publish final or revised draft guidance on biosimilar product labeling.
- Provide more or extra clarity for developers on demonstrating interchangeability.
- Provide additional clarity and flexibility on analytical approaches to evaluating product structure and function.
- Give more support over product quality and manufacturing processes.
- Engage in a public dialogue through a Part 15 hearing and opening a docket to request additional information from the public.
Other players in the biosimilar market include South Korea’s Samsung Bioepis, as well as Amgen, Pfizer and Teva Pharmaceutical.
Celltrion entered the biosimilar market in 2013 with a biosimilar version of Johnson & Johnson and Merck’s Remicade (infliximab), marketed as Remsima. There were apparently doubts at the time as to whether it would be approved at all, but since then the drug has proven to be very successful in Europe. An IQVIA report indicated Remsima had taken over 59% of Remicade’s market share.
Other competing biosimilar products from Celltrion include Truxima, a biosimilar to Roche’s rituximab for cancer and Herzuma, a biosimilar to Roche’s Herceptin for breast cancer. Part of Celltrion’s strategy is to offer “value-added,” versions of its biosimilars, such as a subcutaneously formulation of Remsima, compared to the infused version of the original drug.
Ho Ung Kim, head of Celltrion Healthcare’s medical and marketing division, said, “As a ‘first mover,’ Celltrion Healthcare has gained extensive experience in the biopharmaceutical field and is now ready to initiate a direct sales model.”
He added, “Celltrion Healthcare has set up its own sales network and overseas offices in 14 countries throughout Europe to secure price competitiveness, and strives to lead the global tumor necrosis factor alpha (TNF-alpha) inhibitors market with its innovative infliximab Remsima SC, which is projected to be worth approximately $50 billion.”
