Lupin Limited has announced a strategic partnership that will strengthen its position in the gastroenterology segment across key emerging markets. The global pharmaceutical major disclosed that its subsidiaries in the Philippines and Brazil have entered into an exclusive licensing agreement with Italian pharmaceutical company Neopharmed Gentili S.p.A. for the gastroenterology brand Plasil.

Licensing Agreement Details

The partnership grants Lupin's subsidiaries exclusive marketing and promotional rights for Plasil (metoclopramide) in their respective markets. The agreement involves two key Lupin subsidiaries:

Operational Structure and Supply Chain

The agreement establishes distinct operational frameworks for each market. In the Philippines, Neopharmed will maintain oversight of product supply, ensuring quality standards and compliance with global regulatory requirements. For the Brazilian market, the partnership involves a more integrated approach, with production operations being transferred to Medquimica's existing manufacturing facility.

Strategic Impact and Market Expansion

This collaboration represents a significant enhancement to Lupin's gastroenterology portfolio while expanding the company's footprint in emerging markets. Fabrice Egros, President of Corporate Development at Lupin, emphasized the partnership's importance in expanding access to Plasil, describing it as "one of the most potent anti-emetic treatments" across key emerging markets.

The agreement leverages Lupin's established market presence and regulatory expertise in both the Philippines and Brazil, combined with Neopharmed's distribution network and international reach. This synergy aims to broaden patient access and deliver meaningful health outcomes in both markets.

Product Profile and Therapeutic Applications

Plasil is widely acknowledged for its efficacy in treating multiple gastroenterological conditions:

• Nausea management
• Vomiting treatment
• Motility disorders affecting millions of patients globally

Matteo Meazzini, Director of Business Development at Neopharmed Gentili, highlighted the strategic importance of Brazil and the Philippines as rapidly growing markets, reflecting the company's commitment to expanding its international presence.

Partnership Significance

The collaboration combines Lupin's strong local presence, regulatory expertise, and commercial capabilities in the Philippines and Brazil with Neopharmed's established distribution network. This partnership structure is designed to ensure comprehensive market coverage and enhanced patient access to Plasil treatments in both strategic markets.

Lupin Limited has achieved a significant regulatory milestone with the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopting a positive opinion recommending marketing authorization for its biosimilar ranibizumab, branded as Ranluspec. This positive assessment represents a crucial step toward securing marketing authorization for the biosimilar drug in European Union markets.

Regulatory Approval Details

The CHMP has recommended marketing approval for Lupin's biosimilar ranibizumab Ranluspec in two distinct formulations:

The favorable opinion from CHMP indicates that the biosimilar has met the necessary regulatory standards for safety, efficacy, and quality required for EU market authorization. The positive opinion is based on demonstration of similarity to the reference product, including an analytical similarity assessment.

Clinical Trial Foundation

The CHMP's positive recommendation is supported by comprehensive clinical evidence:

Marketing Partnership with Sandoz

Under the commercial arrangement, Sandoz Group AG will take responsibility for marketing the biosimilar ranibizumab across most European Union territories. This partnership leverages Sandoz's established distribution network and market presence in the European pharmaceutical landscape.

Biosimilar Ranibizumab Significance

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A). Its indications encompass treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), and choroidal neovascularization (CNV).

Thierry Volle, President EMEA and Emerging Markets at Lupin, commented on the achievement: "We are very pleased with the CHMP's positive opinion for ranibizumab. This recognition underscores the quality of Lupin's Biologics development and manufacturing as well as our relentless pursuit of affordable solutions that transform patient care."

The CHMP positive opinion will now be considered by the European Commission (EC) for final marketing authorization across EU member countries, marking an important advancement in Lupin's European biosimilar strategy.