top of page

Creating New Biologics

License or partner on our existing inventory or order a custom Biologic

A revolutionary approach to Biosimilars and Biobetters

There are 100s of FDA-approved Biologics and experimental Biologics in current development. Heligenics can help identify Biosimilar and Biobetter leads by mutagenizing an existing drug and testing ~10,000 mutants. These mutants are assayed against the pathological function associated with the existing gene and its target to identity new protein sequences for the drug that are equivalent to or outperform the existing drug. We can also test a MEGA-Map™ on the receptor for a target and this can be developed with the Biologic into a theranostic to better target the new Biologic as a Biosimilar.

Five values for Biologics

  1. The GigaAssay™ technology is the best way to screen the sequence space for a Biologic

  2. Identify mutants with increased half-life

  3. Identify mutants with stronger biological activity

  4. Identify mutants with better efficacy

  5. Mutant analysis of the receptor for the Biologic can produce a theranostic for Biosimilars


Biosimilars have several advantages over traditional drug development including:

  • Accelerated approvals

  • Lower regulatory risk

  • Established markets with insurance reimbursement​

  • Are most often less costly for FDA approval

The Biosimilar regulatory framework expands upon the Hatch-Waxman amendments passed in 1984 for generic drugs. The 351(k)-application mechanism of Public Health Service Act is used for Biosimilars, which has a reduced time for approval.

Join the functional genome revolution!
Reach out today for more information.
bottom of page