Lupin enters Brazilian oncology biosimilars market with Biomm deal for Pegfilgrastim

Mumbai-based Lupin Limited has taken another step in its global biosimilars push, signing an exclusive distribution and marketing agreement with Biomm SA to bring its biosimilar Pegfilgrastim to Brazil. The move marks a significant expansion into Latin America’s oncology supportive care market, where demand for cost-effective biologics is rising alongside cancer incidence rates.

What does the Lupin–Biomm Pegfilgrastim agreement mean for Brazil’s cancer treatment landscape?

Lupin Limited, one of India’s largest pharmaceutical manufacturers, has announced an exclusive partnership with Brazilian biopharmaceutical company Biomm SA to commercialize its biosimilar version of Pegfilgrastim in Brazil. Under the agreement, Biomm will be responsible for the product’s distribution and marketing, leveraging its established presence in Brazil’s biologics and specialty medicines market.

The agreement covers Lupin’s proposed biosimilar to Neulasta, a Pegfilgrastim reference product originally developed by Amgen Inc. Pegfilgrastim is a long-acting granulocyte colony-stimulating factor (G-CSF) used to reduce the duration of neutropenia and the incidence of febrile neutropenia in cancer patients undergoing chemotherapy.

In October 2021, Lupin secured acceptance from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) for this biosimilar via the 351(k) regulatory pathway. That acceptance signaled the U.S. regulator’s willingness to review the product for eventual market entry, a milestone that also adds credibility to the product’s positioning in other regulated and semi-regulated markets such as Brazil.

Why Pegfilgrastim plays a key role in chemotherapy-related care

Pegfilgrastim is widely prescribed to cancer patients receiving chemotherapy because chemotherapy often suppresses bone marrow function, leading to neutropenia — a dangerous drop in neutrophil count that leaves patients vulnerable to infections. By stimulating the bone marrow to produce more neutrophils, Pegfilgrastim helps maintain immune defense, reduces infection-related hospitalizations, and allows oncologists to maintain optimal chemotherapy dosing schedules without frequent treatment delays.

The branded reference product, Neulasta, has been a mainstay in oncology supportive care since its initial approvals, but its high cost has been a barrier for broader patient access, particularly in developing and middle-income countries. Biosimilar versions, which offer comparable efficacy and safety at a lower cost, have been viewed as a way to widen patient access while reducing healthcare system expenditure.

How Brazil’s oncology biosimilars market is evolving

Brazil’s cancer burden has been rising steadily. According to estimates from the Brazilian National Cancer Institute (INCA), the country records more than 625,000 new cancer cases annually, with breast, prostate, lung, colorectal, and stomach cancers among the most common. Chemotherapy remains a core component of treatment for many of these malignancies, creating significant demand for supportive care agents like Pegfilgrastim.

Brazil’s pharmaceutical market is also increasingly open to biosimilars, especially since the Brazilian Health Regulatory Agency (ANVISA) issued clear regulatory pathways for biosimilar approvals. This regulatory clarity has encouraged multinational and domestic manufacturers to introduce biosimilars for oncology and immunology indications.

By partnering with Biomm — a company with an existing portfolio of biologics for diabetes, oncology, and immunology — Lupin gains local expertise in navigating Brazil’s distribution networks, payer systems, and hospital procurement processes. Biomm’s existing relationships with public and private healthcare providers are expected to be instrumental in establishing market presence for Lupin’s Pegfilgrastim biosimilar.

Why Lupin is targeting Latin America as part of its biosimilars strategy

Lupin has been steadily expanding its biosimilars pipeline, with a focus on therapeutic areas like oncology, endocrinology, and respiratory care. While the company’s generics portfolio is extensive, biosimilars offer higher margins and long-term market potential.

Latin America presents a compelling growth opportunity. The region has been experiencing rising biologics demand but faces cost constraints, making biosimilars a strategic fit. Brazil, as the largest pharmaceutical market in Latin America, accounts for nearly half of the region’s pharmaceutical sales.

The decision to enter Brazil via partnership rather than direct sales reflects both the market’s complexity and the value of local expertise. By aligning with Biomm, Lupin avoids the costs and regulatory challenges of building its own commercial infrastructure from scratch.

How the biosimilar Pegfilgrastim fits into Lupin’s oncology portfolio

Lupin’s biosimilar Pegfilgrastim is part of a broader oncology supportive care strategy. In addition to this product, the Indian pharmaceutical manufacturer has been developing biosimilars for oncology monoclonal antibodies and other growth factors. The aim is to provide a suite of products that can be marketed together to oncology care centers, enhancing commercial efficiency.

The product is developed using advanced recombinant DNA technology, designed to match the reference biologic in terms of molecular structure, potency, safety, and immunogenicity. According to Lupin’s earlier disclosures, clinical trials for the biosimilar demonstrated pharmacokinetic and pharmacodynamic equivalence to Neulasta, as well as a comparable safety profile.

How regulatory progress in the U.S. influences other market entries

The fact that Lupin’s BLA for Pegfilgrastim was accepted by the U.S. FDA before the Brazil agreement adds a layer of validation. While Brazil’s ANVISA conducts its own evaluations, data generated for U.S. and European submissions often plays a key role in supporting regulatory filings in Latin America.

In the competitive biosimilar market, having a product under active review by a top-tier regulator can strengthen negotiations with local distribution partners, improve the perception of product quality, and accelerate decision-making by hospital procurement committees.

What is the market potential for Pegfilgrastim in Brazil and how strong is the competitive landscape?

Brazil’s Pegfilgrastim market, while smaller in volume compared to the U.S. or EU, is strategically important due to its growth trajectory. Biosimilar competition has been intensifying since ANVISA began approving follow-on biologics for oncology. Several multinational companies, including Sandoz and Pfizer, have already launched biosimilar versions of oncology biologics in Brazil.

Lupin’s entry through Biomm will add another competitor to this space, potentially driving down prices and expanding patient access. For public hospitals under Brazil’s Unified Health System (SUS), the arrival of additional suppliers could mean cost savings and more stable supply chains, which are crucial for uninterrupted cancer treatment cycles.

How are industry analysts and market experts viewing the Lupin–Biomm Pegfilgrastim partnership in Brazil?

Industry analysts following the Brazilian pharmaceutical sector have noted that oncology supportive care is becoming an increasingly contested segment. Biosimilars are seen as a “volume play” — companies willing to compete on price while offering high manufacturing quality could capture significant market share.

Market watchers also point out that Biomm’s portfolio alignment with Lupin’s biosimilar Pegfilgrastim could allow for bundling strategies, where hospitals and oncology clinics source multiple biologics from a single supplier for operational efficiency.

While competition will likely pressure margins, the overall market expansion could offset this, particularly as Brazil’s oncology patient population is expected to rise over the coming decade.

What could the Lupin–Biomm Pegfilgrastim launch in Brazil mean for wider Latin American expansion?

If the Pegfilgrastim launch in Brazil proves successful, Lupin could use the Biomm partnership as a platform to introduce additional biosimilars in the market. The collaboration may also open doors to other Latin American countries where Biomm or its affiliates have distribution reach.

For Lupin, the deal represents both a geographic and portfolio diversification move — reducing overreliance on mature generic markets while building a presence in higher-value biologics. For Biomm, the agreement strengthens its oncology supportive care offerings, potentially enhancing its market share in Brazil’s biologics segment.