Kashiv BioSciences bets on Latin America with Cristália deal for Xolair biosimilar

Kashiv BioSciences, LLC, a U.S.-based biopharmaceutical company with an expanding biosimilars portfolio, has signed a licensing and supply agreement with Cristália, one of Brazil’s leading pharmaceutical players, for the commercialization of ADL-018, a proposed omalizumab biosimilar to Xolair, across Latin America. The agreement positions both companies to capitalize on the $140 million omalizumab market in the region, part of a $5 billion global market recorded in 2024 by IQVIA.

Why does Kashiv BioSciences see Latin America as a critical growth market for ADL-018?

Biosimilars are increasingly shaping the biopharmaceutical landscape as governments and healthcare systems push for more affordable access to biologic therapies. Latin America, where healthcare budgets are stretched and branded biologics often face limited patient access due to pricing barriers, represents fertile ground for biosimilar adoption.

By entering into this partnership, Kashiv BioSciences is aligning its strategic expansion with regional market demand. The company has emphasized that Cristália’s established footprint across Latin America makes it an “ideal partner” for distributing ADL-018, which is still an investigational therapy pending regulatory clearance. The U.S.-based biopharmaceutical company will oversee product development, while Cristália will handle licensing, distribution, and commercialization.

How does omalizumab biosimilar ADL-018 compare to Xolair in terms of therapeutic potential?

ADL-018 is designed as a biosimilar to Xolair, a humanized monoclonal antibody that binds to free immunoglobulin E (IgE). Xolair has long been prescribed for chronic idiopathic urticaria (CIU), severe allergic asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergies. For patients across Latin America, many of whom have limited access to high-cost biologics, the introduction of ADL-018 could be transformative.

Xolair has been marketed globally by Genentech, Inc. and Novartis AG, and while patent cliffs and competitive pressure have opened the door to biosimilar entrants, the regulatory path is still stringent. ADL-018 has not yet received approval from any regulatory agency, and Kashiv has clarified that biosimilarity has not yet been established. Nevertheless, the market interest in omalizumab biosimilars is expected to remain high, especially in cost-sensitive regions.

What makes Cristália a strategic partner for biosimilar commercialization in Latin America?

Cristália, headquartered in Campinas, Brazil, has built a reputation as one of the region’s largest privately owned pharmaceutical companies. With 53 years of operations, the company has grown into a diversified biopharma player, spanning discovery, manufacturing, and commercialization of treatments for severe and life-threatening diseases.

The Brazilian company is also among the largest manufacturers of active pharmaceutical ingredients (APIs) in Latin America, with capabilities in synthetic, oncologic, and biotech APIs. This vertical integration provides a strong foundation to handle the complexities of biosimilar commercialization. By partnering with Kashiv BioSciences, Cristália is further strengthening its biosimilar portfolio, reflecting its strategy to make biologic therapies more accessible across Latin America.

How does this agreement fit into global biosimilars market dynamics?

The biosimilars market has accelerated in recent years, driven by blockbuster biologics losing patent exclusivity. For context, the global biosimilars market is projected to grow at double-digit rates, with analysts estimating it could surpass $100 billion within the next decade. Regions like Europe have already embraced biosimilars, while the United States is still catching up following regulatory updates under the Biologics Price Competition and Innovation Act (BPCIA).

In Latin America, biosimilars face unique challenges such as fragmented regulatory frameworks, uneven healthcare access, and pricing sensitivity. However, regional governments have increasingly supported biosimilar adoption to improve affordability. Kashiv BioSciences’ decision to work with Cristália ensures that ADL-018 benefits from a partner that understands these nuances and has deep distribution channels.

What are the potential hurdles for Kashiv BioSciences and Cristália in rolling out ADL-018?

Despite the promise of biosimilars, there are barriers that Kashiv BioSciences and Cristália must navigate. Regulatory approval processes in Latin American markets can be unpredictable, and biosimilarity standards are not uniformly aligned with those in the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA). Building physician and patient trust is also critical, as biosimilars often face skepticism regarding efficacy and safety compared to originator biologics.

Another challenge lies in pricing. While biosimilars are generally expected to launch at a discount of 20% to 40% compared to branded biologics, Latin American markets can be highly price-sensitive. Ensuring that ADL-018 is not only affordable but also profitable will be a balancing act for both companies.

How does Kashiv BioSciences’ broader strategy in biosimilars reinforce this move?

Kashiv BioSciences has positioned itself as one of the few U.S.-based companies with end-to-end biosimilar capabilities, from research and development to manufacturing and commercialization. The company has already secured marketing authorization for multiple biosimilars and is pursuing partnerships globally to extend its footprint.

By advancing ADL-018 in Latin America, Kashiv is reinforcing its goal of expanding access to biologics worldwide. Its vertically integrated structure allows for efficient development and scaling, while partnerships with established local players like Cristália enable faster market penetration.

What does this partnership signal for investors watching biosimilar opportunities in emerging markets?

For institutional investors, the Kashiv–Cristália deal reflects broader momentum in emerging markets biosimilar adoption. Latin America, with its growing demand for affordable biologics, is increasingly attracting global biotech partnerships. While Kashiv BioSciences is privately held and not publicly traded, the agreement underlines a trend that listed companies in the biosimilars space are also pursuing: leveraging regional partnerships to capture market share in cost-sensitive geographies.

In terms of sector sentiment, the deal highlights that biosimilar penetration is no longer confined to developed markets like the EU or U.S. Investors should watch for further licensing agreements across oncology, autoimmune, and respiratory segments in Latin America, which could follow a similar template.

What does the future hold for omalizumab biosimilars in Latin America?

Analysts expect omalizumab biosimilars to play a critical role in reshaping treatment accessibility for allergic asthma and chronic urticaria in the region. If ADL-018 receives regulatory approval, it could quickly capture market share from Xolair by offering cost advantages without compromising therapeutic outcomes.

The Kashiv–Cristália collaboration represents a broader shift in the pharmaceutical industry, where partnerships bridge global expertise with local market presence. If executed effectively, this agreement could set the stage for additional biosimilar launches in Latin America, reinforcing the region’s importance in the global biosimilars growth story.