Prestige Biopharma, an antibody-drug developer, has secured a beachhead to enter the Middle East and North American market with HD201, a Herceptin biosimilar, the company said Tuesday.

The company has signed a contract with Tabuk Pharmaceuticals, a multinational pharmaceutical firm based in Saudi Arabia, obtaining a license for some regions, including Saudi Arabia and the United Arab Emirates, of the Middle East and North Africa (MENA).

The contract comes following Prestige Biopharma’s similar agreement with Cipla, an Indian pharmaceutical firm, completing the entire MENA region's distribution network, the company said. 

Under the latest contract, Prestige Bio will collect royalties on sales profits as well as down payment and milestones. It also will take charge of sales, distribution, and marketing of products. 

Recently, the MENA region has emerged as a growing market with rising demand for antibody therapy, as the regional countries’ per capita drug expenditure and their share of drug expense to GDP have grown. 

Prestige Biopharma expects to carve out a larger market share based on Tabuk’s accumulated know-how and experience and its successful drug releases previously.

HD201 is a Herceptin biosimilar treating breast cancer and metastatic stomach cancer, having shown identical effects to the original drug in clinical trials. 

“Tabuk, the largest local biopharmaceutical company in sales, is the ideal partner of Prestige Bio to commercialize our mainstream biosimilar, HD201, in the MENA region,” CEO Park So-yeon said. “We expect the partnership to become the key to our business success and will strengthen our products’ values in the market.” 

Tabuk CEO Basel Ziyadeh also said, “The partnership agreement will work as a success factor for our business, and I am grateful to become the partner of Prestige Bio, a company with expertise in biosimilar development and successful clinical profile of HD201.”