We are developing dozens of biosimilar products that are in different stages of development for US and global markets; the following products are currently available for licensing; several more cytokines and TNF blocker antibodies are coming in 2019. Write to us to get updates.
Insulin glargine markets are rising sharply
Insulin glargine is expected to exceed Humira sales by 2020; KBL can file it under 505(b)(2) before March 2020.
kbl-124 (insulin glargine (Sarf™ )
Clinical. IND approved FDA subject an in vitro testing under process; now seeking potential Sponsors—full cost of development finalized, commercial supply in place and COGS available for i inspection. Click here to see the status of insulin glargine biosimilars.
Bevacizumab, the first anticancer antibody approved by FDA
Clinical. FDA comments received; protocols, time and cost finalized; IND end 2018. Ready for sponsoring partner. Click here to see the status of bevacizumab biosimilars.
Liraglutide completes the insulin group
KBL-129 (Insulin aspart)
Process development. FDA meeting 2018. Click here to see the status of insulin aspart biosimilars.
Process development. FDA meeting 2018. Click here to see the status of liraglutide biosimilars.
Trastuzumab is the second largest antibody for cancer treatment
Pre-clinical. FDA meeting 2018. Click here to see the status of trastuzumab biosimilars.
Epoetin and darbepoietin are the most established biosimilars
KBL-132 (Erythropoietin alfa)
Process development. FDA meeting 2019. Click here to see the status of erythropoietin biosimilars.
KBL-133 (darbepoetin alfa)
Process development. FDA Meeting 2018. Click here to see the status of darbepoetin biosimilars.