Insulin Gets a Twin: FDA Clears Biocon’s Kirsty as Biosimilar to NovoLog

Biocon Biologics has received approval from the United States Food and Drug Administration (FDA) for its Biologics License Application (BLA) of Kirsty (insulin aspart-xjhz), a Novo Nordisk's NovoLog biosimilar. This is a key step towards introducing more access to affordable diabetes treatment to the United States.

Product Overview
Kirsty is a fast-acting insulin analogue and is used to regulate postprandial blood glucose peak in diabetic patients with diabetes mellitus, both pediatrics and adults.
- It possesses the same pharmacokinetics and effectiveness as NovoLog with no clinically significant differences

- Both 3 mL prefilled pens and 10 mL multi-dose vials for subcutaneous injection
- To be taken 5 to 10 minutes prior to meals.

Regulatory Implications
The FDA's approval of Kirsty contributes to the expanding lineup of biosimilar insulins designed to lower treatment costs and expand access.
- Kirsty is added to Semglee and Rezvoglar in the FDA's insulin biosimilar portfolio

- The greenlight follows after Biocon sorted out production problems at its Malaysian factory, previously raised during inspections

- FDA acknowledged Biocon's compliance corrective actions and third-party assurance of compliance

Market Impact
With over 38 million Americans afflicted with diabetic disease and 8.4 million reliant on insulin therapy, Kirsty's contribution will be certain to increase competition and cost effectiveness. - Biocon's current market presence with Semglee puts it in line for quick market integration - A biosimilar name facilitates substitution at the pharmacy level, subject to interchangeability status.

 Sources: US FDA, Biocon Biologics Corporate Filings, Drugs.com, HCPLive, Fierce Pharma, Pearce IP, India Infoline News Service