Sandoz Group AG

The global generic drugs market is projected to grow from USD 424.2 billion in 2023 to USD 691 billion by 2033, driven by patent expirations, cost-effective medications, and chronic disease prevalence. North America led in 2023 with a 38.4% share. Generics offer affordability and are essential for managing chronic conditions, benefiting patients without comprehensive insurance. The market is supported by FDA approvals, collaborations, and advancements in complex generics, despite challenges like patent litigation.

Big pharma's patent cliff presents a $200 billion opportunity for biosimilar developers, especially with biologics. Five companies—Alvotech, Biocon Biologics, Celltrion, Formycon, and Samsung Bioepis—are highlighted for their biosimilar developments and partnerships, aiming to capitalize on this market shift. The biosimilar market is projected to grow significantly, reaching $150.26 billion by 2033, driven by FDA regulations and demand for affordable treatments.

The idiopathic pulmonary fibrosis market is projected to grow from $3.89 billion in 2023 to $5.24 billion in 2028 at a CAGR of 6.2%, driven by factors like an aging population, limited treatment options, and advancements in diagnostic techniques. Key trends include product innovation and the rise of targeted therapies.

Biosimilar candidates for aflibercept, indicated for age-related macular degeneration (AMD), are progressing towards approval in Europe. Samsung Bioepis' OPUVIZ, Sandoz Group's Afqlir, and Formycon AG/Klinge Biopharma GmbH's FYB203 have all received significant regulatory approvals.

Glenmark Pharmaceuticals USA launches Travoprost Ophthalmic Solution USP, 0.004%, bioequivalent to Sandoz's Travatan Z. The market for Travatan Z achieved $66.2 million in sales (ending Sept 2024). Jim Brown, Senior VP of Sales & Marketing, highlights Glenmark's commitment to high-quality ophthalmic solutions.

Glenmark Pharmaceuticals launched Travoprost Ophthalmic Solution USP, 0.004%, used to reduce eye pressure in glaucoma or high eye pressure patients. The product is bioequivalent to Travatan Ophthalmic Solution USP, 0.004% by Sandoz, Inc. Glenmark's portfolio expansion includes 200 U.S. market products and 51 pending ANDAs with the USFDA. The company reported a net profit of ₹354.4 crore for Q2 FY25.

Antimicrobial resistance (AMR) challenges health systems worldwide, driven by lack of access to first-line antibiotics. Shortages of off-patent antibiotics in the EU lead to increased use of broad-spectrum antibiotics and potential harm to patients. Supply chain insecurity, primarily due to concentrated manufacturing in India and China, exacerbates these shortages. Policy options discussed include administrative and regulatory levers, purchasing arrangements, product mapping and stockpiling, and strengthening manufacturing capacity to improve access to existing antibiotics.

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Merck's subcutaneous Keytruda showed similar characteristics to IV formulation in a Phase 3 trial. The company plans to discuss trial data with FDA and other regulators. Keytruda's U.S. patent expires in 2028, opening the door to biosimilar competitors. Rival Roche has FDA approval for subcutaneous Tecentriq, while Bristol Myers awaits FDA decision on subcutaneous Opdivo. Merck aims to sustain Keytruda's revenue, which reached nearly $22 billion in the first nine months of 2024, by transitioning to a more convenient subcutaneous shot.

Sandoz gains EC approval for Afqlir (aflibercept) 2 mg vial kit and pre-filled syringe for intravitreal injection, a biosimilar to Eylea indicated for retinal diseases like nAMD. Expected to launch Q4 2025, Afqlir aims to provide affordable, effective treatment for European patients with vision-impairing conditions.