News Roundup: Organon Starts Life as a Biosimilars Marketer

June 3, 2021 marks the first day of official life for the biosimilars and women’s health products company Organon, which was formed as a spinoff from Merck.

Organon is based in Jersey City, New Jersey, and has a portfolio of more than 60 medicines and therapeutic products. The company will start life with an estimated $6.5 billion in annual revenue, 80% of that derived from sales outside the United States.

Organon will not be involved in the research side of drug development. Rather, it aims to partner with research and development innovators in bringing their products to market, Organon Chief Financial Officer Matt Walsh told Investor’s Business Daily. “For smaller, more agile, faster-moving innovators, they see a company like ours as the ideal partner because we’re not developing [drugs] ourselves,” he said.

The company’s core business is in contraceptives and fertility products for women, supplemented by other women’s health products and Merck’s former biosimilars portfolio. The company will market infliximab (Renflexis), etanercept (Brenzys, Eticovo), bevacizumab (Aybintio), trastuzumab (Ontruzant) and adalimumab (Hadlima) biosimilars in partnership with Samsung Bioepis of the Republic of Korea.

Other products include dermatology, pain, respiratory, and cardiovascular treatments.

Lupin Files Application for Pegfilgrastim Biosimilar

Mumbai, India-based Lupin said the FDA has accepted its biologics license application for a pegfilgrastim biosimilar candidate referencing Amgen’s Neulasta. The company said the product would target an estimated $3.66 billion market for pegfilgrastim in the United States.

“The pegfilgrastim filing is our first biosimilar filing in the United States and is a milestone in our research and innovation journey,” said Nilesh Gupta, managing director.

Lupin develops and markets branded and generic medicines and biotechnology products in the United States, India, South Africa, the Asia Pacific region, Latin America, Europe, and the Middle East. Those include cardiovascular, antidiabetic, respiratory, anti-infective, gastrointestinal, central nervous system, and women’s health therapeutics. The company states that it is the third largest in the United States by prescriptions sold and maintains a Baltimore, Maryland, office.

Positive Results for Tocilizumab Candidate

Biogen and Bio-Thera Solutions reported positive results from a phase 3 study of a proposed biosimilar tocilizumab (BAT1806), referencing Actemra. “The comparative study met its primary end points and showed equivalent efficacy and [a] comparable safety profile in patients with moderate-to-severe rheumatoid arthritis [RA] inadequately controlled by methotrexate therapy,” they said.

The originator tocilizumab brand is indicated for moderate-to-severe RA in adults, juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome. The primary end point in the study was American College of Rheumatology 20% response criteria.

For Bio-Thera, based in Guangzhou, China, BAT1806 is the third proposed biosimilar the company has developed that has achieved positive phase 3 results. “These results demonstrate the potential of our proposed tocilizumab biosimilar to be a safe and effective treatment,” said Shengfeng Li, PhD, CEO at Bio-Thera.

“We are excited about these results and believe BAT1806 demonstrates equivalence in safety and pharmacokinetics as well as a comparable safety and immunogenicity profile to the reference product,” said Ian Henshaw, head of Global Biosimilars at Biogen, which is based in Cambridge, Massachusetts, and would handle marketing and manufacture of the product in all counties outside of the China area.