Novartis division Sandoz has partnered with Chinese manufacturer Gan & Lee to bring biosimilar insulins to the US and EU.
The agreement will see China’s Gan & Lee supply Sandoz with insulin glargine, lispro and aspart products for use in patients with type 1 and type 2 diabetes for commercialization in Europe and the US, along with other key markets.
“After conducting a significant review, Sandoz decided to collaborate with Gan & Lee, the third largest insulin distributor headquartered in China, due to their 20 years’ experience in insulins and production capacity with attractive cost of goods sold structures,” Sandoz spokesperson Michelle Bauman told BioProcess Insider.
“They also have a series of patented and non-patented technology that optimizes the production process such as increased insulin yield while minimizing costs. Sandoz will support Gan & Lee in manufacturing and development as appropriate.”
Manufacturing details have not been disclosed, but according to Gan & Lee’s website, the firm has accumulated a series of patented and non-patented technology regarding insulin fermentation, refolding, purification and formulation steps. This includes the company’s patented technology ‘Chimeric protein which contains intramolecular chaperon sequence and its application in insulin production,’ which it claims has contributed to the production process optimization, increasing insulin yield while minimizing costs.
‘Literally a matter of life and death for Americans’
Sandoz is a major biosimilar developer with several products launched in both Europe and the US. This is, however, the firm’s first move into biosimilar insulins.
Last week, the US food and Drug Administration (FDA) published a series of documents to help expand the uptake of biosimilars and increase access to life saving drugs. The Agency also announced plans to bring biosimilar insulins into the US market by transitioning so-called follow-on insulin products into biosimilar insulin products by 2020.
“It is clear that the concerns on insulin affordability have been increasingly noted with the US Food and Drug Administration, who recently stated ‘access to affordable insulin is literally a matter of life and death for (certain) Americans,’” Bauman said.
“But across the world, people suffering from diabetes still face very real access challenges. In fact, US patients have reported taking less insulin than recommended by their doctor because they couldn’t afford it. This puts patients at higher risk for serious complications such as blindness, kidney failure and cardiovascular disease.”
She added: “This agreement enables Sandoz to expand our existing endocrinology portfolio over the long-term, in-line with its strategy to expand its biosimilar business and enter the insulins business at attractive investment terms.”