Biosimilar developer Oncobiologics has announced a new strategic partnership with Singapore-based GMS Tenshi Holdings.
Biosimilar developer Oncobiologics has announced a new strategic partnership with Singapore-based GMS Tenshi Holdings. The agreement provides for the private placement of up to $25 million in Oncobiologics’ series A convertible preferred stock as well as 16,750,000 shares of common stock (with an aggregate price of approximately $15 million).
The agreement also includes a joint development and license agreement that provides GMS Tenshi the rights to ONS-3010, an adalimumab (Humira) biosimilar, and ONS-1045, a bevacizumab (Avastin) biosimilar in emerging markets exclusive of China, India, and Mexico. This new agreement replaces a previous arrangement between the companies that licensed only the bevacizumab biosimilar to GMS Tenshi, and resulted in payments to Oncobiologics of $2.5 million.
New Jersey-based Oncobiologics intends to use the proceeds of the private placement to initiate phase 3 clinical trials for its adalimumab biosimilar in 2018. The company says that it intends to pursue a designation of interchangeability with its product and the reference Humira.
“This investment by GMS Tenshi represents the culmination of our efforts to align with a strategic financial partner with a global strategy to accelerate commercialization of our biosimilar candidates and enhance our partnering and licensing capabilities,” said Oncobiologics CEO, Pankaj Mohan, PhD. “We believe that we now have a partner with the necessary financial and global commercial pharmaceutical expertise that…will allow us to realize our vision to bring affordable biologic drugs to patients in need around the world.”
Shares of Oncobiologics rose on news of the new partnership, ending last week at $2.04 per share (an increase of 126%). The company will need to secure stockholder approval of its agreement at its annual meeting, and will file a proxy statement with the US Securities and Exchange Commission in the interim.
In addition to the 2 drugs covered by its new agreement with GMS Tenshi, the biosimilar developer also reports 2 additional products in its pipeline: ONS-1050, a trastuzumab (Herceptin) biosimilar, and ONS-4010, a denosumab (Prolia, Xgeva) biosimilar. The company expects to initiate phase 1 trials for both products in 2018.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.