Evaluation of physicochemical and biological properties of nonreconstituted MYL-1401O vials, reconstituted MYL-1401O suspension in vial, and diluted MYL-1401O suspension in infusion bags (0.9% saline) for extended duration

ABSTRACT

Background

MYL-1401O; trastuzumab-dkst (Ogivri™; Mylan Inc.) is a biosimilar to the trastuzumab reference product (Herceptin®; Genentech, USA). Assessment of physicochemical stability and biological activity for the non-reconstituted, reconstituted, and infused solution over an extended, clinically relevant duration is critical for ensuring optimal patient outcomes and health resource utilization.

Methods

The physicochemical and biological stability of MYL-1401O was assessed in non-reconstituted vials stored at 25 °C ± 2 °C/60% ± 5% relative humidity (RH) for 6 months, reconstituted 21 mg/mL solution in vials stored at 2 °C to 8 °C for 10 days, and diluted in 0.9% saline-containing infusion bags at 0.3 mg/mL and 4.0 mg/mL stored for 77 days at 2 °C to 8 °C, plus an additional 2 days at 25 °C ± 2 °C/60% ± 5% RH.

Results

At all storage conditions tested, MYL-1401O was physicochemically and biologically stable for extended duration and under various temperature and humidity conditions.

Conclusions

MYL-1401O retained its physicochemical and biological stability under different storage conditions, which supports advanced preparation of MYL-1401O, better efficiency, less wastage, and cost-savings for better patient management.

KEYWORDS:

• Biosimilar
• MYL-1401O
• physicochemical
• biological activity
• stability
• trastuzumab

Declarations of interests

Bhavesh Vats is an employee of Viatris (formerly Mylan) Pharmaceuticals Private Limited. Parag Goyal is a shareholder and employee of Viatris (formerly Mylan, Inc.), Zacharia Mathew, Ranendu Ghosh, Moram Narendra Babu, Rahul Singh Jadav, Arya M Nair, Malini Subbarao, Arnab Bera, Kirthi, Prakash Sadasivappa, Pradeep Kabadi, Chethan Gejjalagere Honnappa, Ankita Singh, and Anusha Valiya Parambath are employees of Biocon Biologics India Limited. Anindya Sarkar and Uma Sankar Patnaik are employees of Viatris (formerly Mylan) Pharmaceuticals Private Limited. Rajesh Ullanat is an employee and shareholder of Viatris (formerly Mylan) Pharmaceuticals Private Limited. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Author contributions

The authors involved in the conception and design or analysis/interpretation and review of the manuscript are Bhavesh Vats, Parag Goyal, Ranendu Ghosh, Malini Subbarao, and Zacharia Mathew. All other authors contributed to the generation of the data and analysis that comprise this manuscript. All authors have agreed to the final version to be published and agree to be accountable for all aspects of the work.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

Funding for this study and preparation of this manuscript was provided Mylan Inc. Canonsburg, PA, USA.