1. Generics Bulletin
  2. >>Business
  3. >>Manufacturing

US FDA Pushing For Generic Alternatives To Long-Acting Injectables, Implants

 
• By Joanne S. Eglovitch

Complexity of manufacturing process for long-acting polymer-based injectable drugs, implants and in situ forming gels is delaying development of generic alternatives, but the US FDA hopes that new research into the formulation of these drugs will shed some light on how manufacturing processes can be replicated.

FDA entrance sign 2016

The US FDA anticipates that new research will provide more insight on the processes used to manufacture long-acting polymer based implants and injectable drugs in order to spur generic drug development. Officials are concerned that the complexity posed in manufacturing these drugs is delaying the development of generic alternatives.

Called PLGA (polylactic co-glycolic acid) these are biodegradable polymers which are key components of long-acting release drug products. PLGAs can...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Manufacturing

Reshaped Xbrane Allies With OneSource For Commercial Biosimilar Manufacturing

 
• By Dean Rudge

Xbrane Biopharma is partnering with India’s OneSource Specialty Pharma to manufacture its biosimilars, including its much-delayed ranibizumab product Ximluci. The move follows a SEK240m funding round and strategic refocus on commercialization after divesting key R&D assets to Alvotech.

Xbrane Sets Date For Latest Run At Ranibizumab In US

 
• By Dave Wallace

After a series of setbacks for its Lucentis (ranibizumab) biosimilar filing in the US, Xbrane Biopharma now has a fresh action date from the FDA – although any approval will be contingent on a successful agency reinspection of its manufacturing sites.

Zydus Strikes Landmark $141m Agreement To Break Into Global CDMO Business

 
• By Dean Rudge

Zydus Lifesciences said it would be able to leverage supply chain dynamics and a “favorable geopolitical environment” to expand its reach in the US and globally as it penned a trio of agreements to plant its flag in the global CDMO space.

Glenmark Adamant FDA Monroe Site Reinspection Could Happen ‘Any Time’

 
• By Dean Rudge

A weak second half in Glenmark’s India business during the firm’s 2025 financial year took the gloss off its earnings somewhat for the year. However, Glenmark is plotting several avenues to return to growth, in both of its core business regions: India and the US.

More from Business

Teva Continues Push Beyond Generics in Fosun Immunotherapy Tie-Up

 
• By Dean Rudge

Teva has agreed to partner with China’s Fosun Pharma to develop TEV-56278, a targeted cancer immunotherapy, marking the next step in its continued pivot from its generics roots toward complex biologics and innovative oncology treatments. The deal covers key Asian markets, including mainland China, w

Big Top-Level Shifts At Sun: Ganorkar Is MD, Ex-Takeda Exec To Helm US Business

 
• By Anju Ghangurde

Sun’s founder hands top job to company longtimer Kirti Ganorkar as the firm implements a “structured and forward-looking” succession plan, while Richard Ascroft will lead the Indian drugmaker’s North America business.

‘I Saw An Unpolished Diamond’: Iconovo CEO Wäborg On Breaking Even In 2027 And Beyond

 
• By Dean Rudge

In an exclusive interview, Iconovo CEO Johan Wäborg outlines the company’s strategy to become a leader in dry powder inhalation by focusing on platform development, reformulated therapies, and B2B licensing, with a plan to break even by 2027.