Weekly Pharma Update: NEXPLANON Extension & Biosimilars

FDA Approves Extended-Use NEXPLANON® Implant

What’s new: The U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for NEXPLANON® (etonogestrel implant) extending its duration of use up to 5 years, including data supporting use in women across different BMI ranges.
Why it matters: This expands contraceptive choice and convenience, reducing the frequency of replacement procedures and potentially improving adherence across diverse populations.
Source: Organon press release (16 Jan 2026). 
 

Novartis’s Ianalumab Receives FDA Breakthrough Therapy Designation

What’s new: The FDA granted Breakthrough Therapy designation to ianalumab for the treatment of Sjögren’s disease, a chronic autoimmune condition with significant unmet medical need and no approved targeted therapies to date.
Why it matters: Breakthrough Therapy status can expedite development and review, signaling strong early clinical evidence and priority for regulatory interaction.
Source: Novartis press release (16 Jan 2026).
 

FDA & EMA Approvals for Advanced Therapy “Waskyra™”

What’s new: AGC Biologics celebrated both FDA approval and a positive EMA CHMP opinion for Waskyra™, an advanced genetically modified cell therapy developed in partnership with Fondazione Telethon for patients with Wiskott–Aldrich syndrome (WAS).
Why it matters: Dual regulatory progress in the U.S. and EU underscores accelerated global access for a life-saving gene/cell therapy in a rare immunodeficiency disorder.
Source: AGC Biologics press release (16 Jan 2026).
 

EMA Recommends Biosimilar Approvals

What’s new: The European Medicines Agency’s CHMP issued positive opinions for two biosimilars: Ondibta® (insulin glargine) for diabetes and Osqay® (denosumab) for osteoporosis and bone loss.
Why it matters: These biosimilars are poised to enhance competition and expand access to insulin and bone health therapies across the EU once formally approved by the European Commission.
Source: EMA biosimilars report.
 

Halozyme & Takeda Global Licensing Collaboration

What’s new: Halozyme Therapeutics signed a global collaboration and exclusive license agreement with Takeda to develop and commercialize vedolizumab with ENHANZE® (Halozyme’s proprietary recombinant human hyaluronidase) for enhanced delivery.
Why it matters: The partnership leverages improved subcutaneous dosing platforms to expand patient convenience and market reach for Takeda’s immune-mediated disease therapy.
Source: Halozyme press release
 

FDA Approves Denosumab Biosimilars

What’s new: The FDA approved new denosumab biosimilars, broadening treatment options for osteoporosis and bone complications linked to cancer therapy while intensifying cost competition in the biologics category.
Why it matters: This expands patient access to bone density therapies and reinforces the trend of biosimilar market expansion in 2025–2026.
Source: Center for Biosimilars coverage
 

Industry & Strategic Context

Pharma Sector Doubles Down on AI for R&D Efficiency

Pharmaceutical companies are accelerating adoption of artificial intelligence to cut early-stage research costs and timelines, with AI tools increasingly integrated into drug discovery and clinical planning.
Source: Reuters industry analysis (reported mid-Jan 2026).
 

PAGE Academy Launches to Boost Pharma Skilling in India

Union and state leaders launched the Pharmaceutical Academy for Global Excellence (PAGE) in Ahmedabad, enhancing workforce skilling, manufacturing quality, and India’s pharma leadership under the Atmanirbhar Bharat vision.
Source: The Times of India (reported recently).
 

Telangana to Unveil Next-Gen Life Sciences Policy at Davos

Telangana aims to launch a Next-Gen Life Sciences Policy 2026–2030 at the World Economic Forum in Davos, positioning the state as a leader in vaccines, advanced therapies, and sustainable pharma manufacturing.
Source: The Times of India (reported recently).

Key Themes