Glenmark's European Gambit: Winlevi Launch to Disrupt Acne Market

DUBLIN & MUMBAI – December 01, 2025 – The European Commission has officially granted Marketing Authorization for Winlevi®, a novel topical acne treatment, setting the stage for one of the most significant strategic plays in the European dermatology market in years. The approval, announced by partners Cosmo Pharmaceuticals and Glenmark Pharmaceuticals, is far more than a simple regulatory milestone; it represents a calculated push by Glenmark to redefine its European presence and a major validation of Cosmo's innovation-focused partnership model.

Following a positive opinion from the European Medicines Agency's CHMP in August, the decision greenlights Winlevi® (clascoterone 10 mg/g cream) for acne vulgaris in patients 12 years and older across 17 European nations. For Glenmark, which will spearhead the commercialization, this is not just another product launch. It is the company's first-ever New Chemical Entity (NCE) to be launched in Europe, a move that signals a profound strategic shift from a generics-focused firm to a research-led global competitor.

A First-in-Class Disruptor

The strategic weight of this launch is anchored in Winlevi's unique scientific profile. It is the first topical androgen receptor inhibitor approved for acne, representing the first truly new mechanism of action for a topical acne treatment to gain regulatory approval in nearly four decades. This is a significant breakthrough in a therapeutic area often characterized by incremental improvements on existing drug classes.

Clascoterone, the active ingredient, works by directly targeting androgen receptors in the skin's sebaceous glands. This is believed to reduce sebum production and inflammation—two primary drivers of acne—without the systemic side effects associated with oral anti-androgen therapies. This localized action makes it suitable for both male and female patients, a key differentiator from some systemic treatments restricted to women.

Crucially, Winlevi is a non-antibiotic therapy. In a European healthcare environment increasingly concerned with the global threat of antimicrobial resistance, this feature provides a powerful competitive advantage. European dermatology guidelines have been moving away from topical antibiotics for acne, creating a clear unmet need that Winlevi is perfectly positioned to fill. Clinical data from two pivotal Phase III trials underscores its potential, showing statistically significant improvements in treatment success rates and lesion reduction compared to a placebo, all while maintaining a favorable safety profile with mostly mild and localized skin reactions.

Glenmark's Strategic European Push

For Mumbai-based Glenmark Pharmaceuticals, the Winlevi launch is the centerpiece of a larger corporate transformation. The company has publicly stated its ambition to evolve into a research-led, global pharmaceutical powerhouse, and this approval serves as the first major proof point of that strategy in the competitive European market.

As Christoph Stoller, President & Business Head for Europe and Emerging Markets at Glenmark, noted, "Winlevi is the first NCE launch of Glenmark in Europe and is key to strengthening our presence in Dermatology in the region." This move diversifies Glenmark's portfolio beyond its traditional strengths and plants a flag firmly in the high-margin specialty branded market. The company is betting that its "half-century-long experience in dermatology" will provide the commercial infrastructure and expertise needed to make Winlevi a blockbuster.

The decision to launch an innovative, premium-priced product marks a deliberate pivot. It requires a different commercial muscle than marketing generics—one focused on educating dermatologists about a novel mechanism, navigating complex reimbursement negotiations, and building a brand from the ground up. Success here would not only generate significant revenue but also elevate Glenmark's credibility as an innovator across the continent.

The Blueprint for Success: US Launch and Partnership Dynamics

Glenmark is not entering this venture blind. The company can look to Winlevi's impressive track record in the United States as a blueprint for success. Since its U.S. launch in 2021, Winlevi has become the most-prescribed branded topical acne drug, with sales reaching $28 million in 2022. By mid-2023, over 15,000 U.S. healthcare providers had prescribed the drug, making it one of the most successful topical acne launches in the past 15 years.

This performance demonstrates a clear demand for Winlevi's unique profile among both clinicians and patients, de-risking the European launch to a significant degree. The strategic partnership between Glenmark and Dublin-based Cosmo Pharmaceuticals is the engine driving this global expansion. Under the terms of their 2023 agreement, Cosmo, which developed the drug, is responsible for manufacturing and supply. In return, Cosmo received a $5 million upfront payment and is eligible for substantial double-digit milestones and royalties on net sales.

This symbiotic relationship allows each company to play to its strengths. Cosmo focuses on its core competency of R&D and innovation, monetizing its intellectual property through strategic licensing deals across the globe. Giovanni Di Napoli, CEO of Cosmo, highlighted this, stating, "This approval reflects the strength of our collaboration with Glenmark and our shared commitment to advancing dermatologic care." Meanwhile, Glenmark leverages its established commercial footprint to execute the market rollout.

Navigating the Complex Commercial Landscape

Despite the promising clinical profile and U.S. success, the road ahead in Europe is complex. Glenmark must navigate the fragmented healthcare landscape of 17 different countries, including major markets like France, Spain, and the Netherlands, each with its own pricing, reimbursement, and regulatory hurdles.

The European acne treatment market is substantial, valued at over $1.1 billion in 2024 and projected to grow at a nearly 5% CAGR. However, gaining favorable reimbursement will be critical. Winlevi's premium positioning—its U.S. price is notably higher than many generic alternatives—will face scrutiny from cost-conscious national health systems. Glenmark's ability to effectively communicate the drug's value proposition, particularly its non-antibiotic nature and novel mechanism, will be paramount in these negotiations.

Executing a coordinated and effective launch across such a diverse territory is a formidable operational challenge. Glenmark's stated commitment to "executing successful launches with urgency and precision" will be put to the test. The company’s performance over the next 18-24 months will not only determine Winlevi's fate in Europe but will also serve as a defining indicator of whether Glenmark has truly arrived as a major player in the global specialty pharmaceutical arena.