Lupin Limited has announced a strategic collaboration with LABORATORIOS ERN S.A. for the launch of Luforbec® (beclometasone/formoterol) 100/6 in Spain. This fixed dose combination, delivered via a pressurized metered dose inhaler (pMDI), is intended for the regular treatment of adult asthma and chronic obstructive pulmonary disease (COPD). The partnership leverages Lupin's global respiratory expertise and ERN's established national reach to enhance access to quality respiratory care for patients across Spain.

Partnership Overview

The collaboration targets the Spanish market, aiming to address the therapeutic needs of adults managing asthma and COPD. By combining Lupin's manufacturing capabilities with ERN's local distribution network, the alliance seeks to deliver proven respiratory therapies to a broader patient population.

Strategic Significance

Thierry Volle, President EMEA and Emerging Markets at Lupin, highlighted that the launch in Spain follows successful introductions in the UK and Germany. He emphasized that this milestone reinforces the company's commitment to advancing global access to quality respiratory care. David Solanes, CEO of LABORATORIOS ERN, S.A., noted that the partnership allows the introduction of a high-value therapy to Spanish patients and represents an expansion into a new therapeutic area for ERN.

Product Indications

Luforbec® is indicated for the regular treatment of asthma where a combination of inhaled corticosteroid and long-acting beta2-agonist (ICS/LABA) is appropriate. This includes patients not adequately controlled with ICS and 'as needed' inhaled short-acting beta2-agonist, or those already controlled on both ICS and LABA. Additionally, it is indicated for the symptomatic treatment of severe COPD (FEV1 < 50% predicted normal) in patients with a history of repeated exacerbations who have significant symptoms despite regular therapy with long-acting bronchodilators.

Lupin Limited received approval from the U.S. FDA for Ranluspec, an interchangeable biosimilar referencing Lucentis, on June 4, 2026. This approval marks Ranluspec as the only interchangeable biosimilar ranibizumab approved in the United States available in both vials and pre-filled syringes (PFS). The drug is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.

Both the vial and PFS presentations are approved in two strengths: 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL). Ranibizumab functions as a recombinant humanized IgG1 monoclonal antibody fragment that binds and inhibits vascular endothelial growth factor A.

Executive Commentary

Vinita Gupta, CEO, Lupin, stated that the approval adds depth to the company's biosimilars portfolio and reflects progress in complex biologics. Nilesh Gupta, Managing Director, Lupin, noted that the approval reinforces scientific rigor and manufacturing capabilities. Dr. Cyrus Karkaria, President Biotechnology, Lupin, highlighted the company's expertise in biologics development and manufacturing.

Product Details