The Guangdong, China–based generics manufacturer and its commercialization partner Lanexa Biologics, received FDA approval for their insulin glargine biosimilar Langlara. In addition to its insulin glargine product, which is approved in China, other biosimilars may follow based on Sunshine Lake’s other existing insulin formulations.
Another insulin glargine biosimilar has joined the ranks of Semglee and Rezvolglar. A new, lesser-known manufacturer from China has received its first FDA approval, joining the ranks of insulin glargine competitors in the US. The product, Langlara (insulin glargine-aldy) was approved by the FDA in late April. Langlara is manufactured by Guandong, China–based Sunshine Lake Pharma Co, Ltd (we think–see below).
The drug will be commercialized in the US by a Lannett subsidiary called Lanexa Biologics. Lannett had an insulin glargine biosimilar in the pipeline, and was expected to file for FDA approval several years ago. Instead, it filed for Chapter 11 bankruptcy. Lannett emerged from bankruptcy in June 2023. In July 2025, Aurobindo Pharma began the process of acquiring Lannett. According to Lannett, upon completion of the acquisition, Lanexa Biologics will become a free-standing company, and will focus exclusively on biosimilar commercialization in the US.
Tim Crew, CEO of Lannett, stated, “Often, the greatest barrier to care for patients living with diabetes is the cost or the availability of the medicine itself. Upon the launch of Langlara, supported by the tremendous manufacturing scale of our partner, patients will have expanded access to a safe, affordable and available treatment option.”
It is unknown at present whether (or how) this biosimilar approval is related to the earlier Lannett drug candidate. However, Lannett’s press release also refers to a collaboration with Sunshine Lake Pharma on the latter’s short-acting insulin aspart biosimilar candidate, which is also approved in China. Sunshine Lake Pharma also has an R human insulin and 70/30 mix insulin among its product portfolio.
The Chinese-end of this partnership is possibly even more complex. Clicking on the website for Sunshine Lake Pharma leads to HECpharm.com, which also operates under the name Guangdong Dongguangyang Pharmaceutical. The HECpharm.com website explains that Dongguangyang Pharmaceutical was founded in 2003, the same date as listed for Sunshine Lake Pharma. A merger occurred between Sunshine Lake and a Dongguangyang Changjiang Pharmaceutical, in 2025, and yet another name is mentioned on the website—Dongguangyang Lake. In the US, a subsidiary named HEC Pharm USA Inc is based in Plainsboro, New Jersey, but that website’s link was inoperative when checked for this article. Yet, the FDA’s approval letter for Langlara was directed to “Sunshine Lake Pharma Co, Ltd, c/o HEC Pharm USA Inc,” indicating that HEC Pharm USA was operating as the liaison with the FDA during the approval process. Perhaps HEC Pharm is a parent company in this maze of entities. In any case, there is a new insulin glargine biosimilar approved in the US on behalf of a confusing organization in China!
This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated biosimilar approval database.
