Ways2Capital Reviews : Biocon To Present Data On Two Biosimilars At ASCO Meeting Ahead Of Pegfilgrastim TAD

Biocon/Mylan have announced that they will present clinical trial results for Ogivri (biosimilar of Herceptin) at 2018 American Society of Clinical Oncology (ASCO). The Heritage clinical trial study showed that Ogivri is highly similar to Herceptin and there is no clinically meaningful difference between the biosimilar product and Herceptin in terms of safety, purity and potency. Biocon/Mylan have also said that another proposed biosimilar to Neulasta (Pegfilgrastim) has been selected for publication in the 2018 ASCO Annual Meeting.

Ogivri is the first approved biosimilar of Trastuzumab. Biocon/Mylan received the USFDA approval for Ogivri in December 2017. It is approved to treat of breast cancer or stomach cancer.

Ogivri is the first approved product developed through the Biocon/Mylan partnership and there are total six products to follow in due course of the time. The approval to Trastuzumab biosimilar was delayed by a few months due to the USFDA queries on the product. Mylan will exclusively commercialize Ogivri in the US, Canada, Japan, Australia, New Zealand and Europe while Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

Biocon/Mylan have also submitted the Pegfilgrastim biosimilar to the USFDA and the target action date for the same is set as June 04, 2018, i.e. today. Target action date is a day on which USFDA will announce its decision on a product.

Biocon received seven form 483 observations at it's at Bengaluru facility in the pre-approval inspection. These observations are mostly related to the cleaning procedures not related to data integrity and hence a delay in the product approval is not expected. The company has also responded to the Complete Response Letter (CRL) issued by the USFDA on Pegfilgrastim. CRL and pre-approval is common procedure before USFDA approval to the drug.

Trastuzumab has US market of $2.7bn while Pegfilgrastim has US market of ~$4bn and when launched, both the Biosimilars will bring more than $500mn in PAT over next four years for Biocon.

Read Biocon's Q4FY18 result analysis and conference call notes on our website. 

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