US FDA Biosimilar Updates
Record Approvals: Over 12 biosimilars approved in the first half of 2025 alone, spanning immunology, oncology, endocrinology, and metabolic disorders. Denosumab Surge: Multiple biosimilars referencing Prolia/Xgeva (denosumab) were greenlit, reflecting growing demand in bone health and cancer care. Interchangeability Simplified: The FDA eliminated the need for switching studies to gain interchangeable status, aligning with EU and WHO standards
š§Ŗ Notable Approvals
Biosimilar Name Reference Product Approval Date
Starjemza Stelara (ustekinumab) May 2025
Bomyntra Xgeva (denosumab) Mar 2025
Hadlima Humira (adalimumab) Interchangeable status granted
š” Industry Impact Biosimilars now target high-cost biologics, offering affordable alternatives and reshaping U.S. drug pricing dynamics. The FDAās streamlined regulatory approach is accelerating market adoption and patient access.
Few tips for get better results in examination
š§ 1. Understand, Donāt Memorize
Focus on grasping core concepts rather than rote learning. Use analogies, mind maps, or teach the topic to someone elseāit locks in understanding.
ā³ 2. Smart Time Management Break study sessions into 25ā30 minute chunks (Pomodoro technique). Prioritize high-weight topics and practice past papers under timed conditions. āļø 3. Active Recall & Practice Quiz yourself regularly instead of just rereading notes. Solve sample questions and mock tests to build confidence and speed.
š¤ 4. Sleep Is Non-Negotiable A well-rested brain retains more and performs better. Avoid all-nightersāopt for consistent sleep and short naps if needed.
š„ 5. Fuel Your Brain Eat light, nutritious mealsāthink fruits, nuts, and water. Avoid heavy or junk food before study or exams to stay alert.
š§ 6. Stay Calm & Focused Practice deep breathing or short meditation to reduce anxiety. Visualize successāsee yourself walking out of the exam smiling.
