Evergreen With Envy: Halozyme’s Subcutaneous Conversions Grow As Rivals Hope To Break In

Halozyme’s Enhanze technology has now brought seven monoclonal antibodies, including Ocrevus and Tecentriq, from IV to subcutaneous delivery, but Alteogen and other high-concentration formulation players hope to join the party as Medicare pricing issues help drive interest.

sparkling evergreen tree
With two recent approvals, subcutaneous conversions continue to sparkle as line extensions for established products. • Source: Shutterstock

The US FDA’s back-to-back approvals of Genentech’s Tecentriq Hybreza and Ocrevus Zunovo place a spotlight on biologics delivery specialist Halozyme Therapeutics, whose Enhanze technology has now brought subcutaneous dosing to seven monoclonal antibodies on the US market.

More from US FDA Performance Tracker

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

US FDA’s March Approval Candidates Take Aim At Established Markets

 

March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.

GSK’s Penmenvy, Bavarian Nordic’s Vimkunya Clear US FDA, Will CDC Follow?

 

The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.

Rapidly Rising RMAT Designations Crack CBER’s Communication Freeze

 

The US FDA is receiving more requests for regenerative medicine advanced therapy designation and granting more of them, according to recently reported agency data.

More from Regulatory Trackers

EU Decision Time For Topical Gene Therapy Beremagene Geperpavec And Five Others

 

The European Medicines Agency is set to issue opinions this week on whether pan-EU marketing approval should be granted to a number of new products.

GSK’s Penmenvy, Bavarian Nordic’s Vimkunya Clear US FDA, Will CDC Follow?

 

The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.

First Lassa Fever Vaccine Wins EMA PRIME Designation; Advanced Therapies Dominate 2024 Entries

 

Two investigational products have made it onto the European Medicines Agency’s priority medicines scheme so far this year. Meanwhile, of the 14 products that entered the scheme last year, six were advanced therapies.