Tony Hagen is senior managing editor for The Center for Biosimilars®.
The Center for Biosimilars® reports on developments at the International Generic and Biosimilar Medicines Association (IGBA), Celltrion, Innovent Biologics, and Kamada.
The International Generic and Biosimilar Medicines Association (IGBA), a trade group with global corporate membership, has appointed a new chair for 2021: Sudarshan Jain, PGDM, secretary general of the Indian Pharmaceutical Alliance. He replaces outgoing IGBA Chair Hanan Sboul.
Jain was described as a veteran of the pharma industry with many years of leadership and drug policy experience. “Increased and sustainable patient access to high quality medicines worldwide, as well as balanaced intellectual property systems remain our key priorities,” he said in a statement.
“More than ever, we need to transform the lessons learned from the current pandemic and public health crises into resilience of the supply chain of active pharmaceutical ingredients and finished products and ensure that the needs of patients and their access to affordable, safe, and effective generic biosimilar medicines are taken into account in trade agreements,” Jain said.
The IGBA made use of the occasion to tout its achievements in 2020. The group signed an affirmation with the World Health Organization that the two would partner in easing registration of generics and biosimilars and simplifying the biosimilar approval process.
IGBA noted a study it conducted jointly with IQVIA to counter arguments that reducing product exclusivity terms would cause a reduction in investment in new and improved medicines. The group claimed to have found numerous examples of how originator product exclusivity protections reduced the savings that would have resulted from generic and biosimilar competition.
The group also produced an advisory for regulatory authorities that offered ideas for improving conditions for a sustained, competitive biosimilar market. These guidelines called for streamlining regulatory policies for biosimilars, with an emphasis on those governing biosimilar development. The group noted improvements in analytical analysis for the support of biosimilar approvals and added its own argument to the weight of opinion forming against the need for comparative clinical efficacy trials of biosimilars, which are often considered redundant and not as useful for regulatory decisions on these agents.
IGBA also launched a campaign to promote biosimilars it called Global Biosimilars Week, which was in November 2020.
Celltrion of Incheon, Republic of Korea, has filed an investigational new drug (IND) application with the FDA for its biosimilar candidate referencing denosumab (Prolia), for which there currently are no biosimilars available on the US market. An IND is filed when a company wishes to test a drug candidate in humans. Celltrion aims to launch a phase 3 clinical trial of the denosumab candidate (CT-P41), recruiting 416 patients, and complete the trial by the early half of 2024, according to a Korean press report.
Denosumab is an injectable indicated for the treatment of patients with bone health issues, such as osteoporosis and hypercalcemia. The originator company is Amgen, and denosumab was first approved in June 2010, with an indication for high-fracture risk postmenopausal osteoporosis. Further indications were later added for bone loss in patients with prostate and breast cancer, men with high-fracture-risk osteoporosis, and glucocorticoid-induced osteoporosis.
Amgen reported $2.7 billion in 2010 revenues for the product, vs $2.3 billion in 2018. In third-quarter 2020 results, denosumab revenues were up 11% quarter over comparable quarter, indicating continued growth.
There are no denosumab biosimilars available in Europe.
Innovent Biologics, of Suzhou, Jiangsu, China, has announced a string of developments related to its bevacizumab biosimilar, Byvasda. After reporting that the National Medical Products Administration (NMPA) of China approved Byvasda for the treatment of adult recurrent glioblastoma, in late December 2020, Innovent this week stated that the NMPA had accepted a supplemental new drug application for the company’s sintilimab injection (Tyvyt) for use in combination with Byvasda as first-line therapy for patients with hepatocellular carcinoma.
Kamada, an Israel-based company with rabies and lung disease products in circulation, has signed agreements to distribute biosimilars in Israel on behalf of 2 unnamed international biopharmaceutical companies, the company said in a statement.
Kamada has previously signed an agreement with Alvotech of Reykjavik, Iceland, for the Israel-based commercialization of 6 biosimilars still under development. The new agreements involve 3 biosimilar product candidates that Kamada anticipates bringing to market between 2022 and 2024.
In the United States, the company markets the protease inhibitor alpha-1 antitrypsin (Glassia) for the treatment of lung problems caused by an inability to fight off bacteria.