Thermicra™ · For biosimilar developers
Your biosimilar.Subcutaneous.No hyaluronidase.
- A marketed antibody's concentration, without hyaluronidase
- 3×A marketed antibody's concentration, without hyaluronidase
- Of the injection volume
- 1/3Of the injection volume
- Stable, with binding activity kept
- 6 monthsStable, with binding activity kept
01 — The bottleneck
Most IV-to-SC switches run through one enzyme.
01
One enabling technology
Most antibody IV-to-SC conversions co-formulate the drug with recombinant hyaluronidase, which loosens the tissue so a larger volume can go under the skin. Access to that enzyme is limited.
02
A patent wall around it
The enzyme, its formulations and its uses sit under dense patent families held by a few companies. Even after an antibody's own patents expire, an SC biosimilar can stay blocked or delayed by them.
03
SC biosimilars arrive late
The result: an IV-only biosimilar competing against an originator that patients and clinics already take subcutaneously — or a long wait, or a license on someone else's terms.
- Antibody patentsExpire: IV biosimilars launch
- Hyaluronidase patent familiesStill in force: SC biosimilars wait
- Thermicra SC routeNo hyaluronidase: SC as soon as the antibody is free
02 — The Thermicra route
From your IV drug substance to an SC biobetter.
1
Your IV biosimilar drug substance
Bring the drug substance you already make and characterize. Nothing changes upstream.
2
Thermicra ultra-high-concentration SC formulation
We concentrate it to SC strength while keeping viscosity injectable — without hyaluronidase.
3
An SC biobetter
A differentiated SC product, developed outside the hyaluronidase patent families, instead of one more IV copy.
03 — Proven on antibodies
Already proven on marketed antibodies.
Plasma concentration SD rat
Anti-IL-4Rα IgG4, single 10 mg/kg SC dose: the marketed product at 150 mg/mL and Thermicra Formulations 1 and 2 at 450 mg/mL
Marketed product · 150 mg/mLFormulation 1 · 450 mg/mLFormulation 2 · 450 mg/mL
Profiles overlapCell binding Anti-PD-1 antibody
The marketed product and the same antibody as Thermicra particles
Marketed productThermicra formulation
No significant difference3×
The marketed concentration: 150 → 450 mg/mL, same anti-IL-4Rα IgG4
1/3
Of the injection volume, at the same dose
4
Marketed antibodies tested, by target: anti-IL-4Rα, anti-HER2, anti-CD38 and anti-PD-1
No hyaluronidase needed
An anti-HER2 antibody in Thermicra reached a bioavailability comparable to the marketed hyaluronidase-based SC product — without the enzyme.
Binding activity intact
Binding matched the reference for anti-IL-4Rα (94%), anti-CD38 and anti-PD-1 antibodies — within the ≥90% acceptance criterion.
Stable for 6 months
An anti-CD38 antibody kept 98.5% of its binding activity after 6 months long-term, and 91.5% under accelerated conditions.
Clears like a normal SC dose
Fluorescence imaging showed the same injection-site clearance as an IgG solution: the formulation does not hold the drug back.
SC with hyaluronidase
Fibroplasia in the subcutis (minimal)
Thermicra SC
No remarkable finding
04 — Side by side
Same antibody. A different path.
| Hyaluronidase-based SC | Thermicra SC | |
|---|---|---|
| Hyaluronidase in the product | Required | None |
| Enzyme supply | Licensed from a limited source | Not needed |
| Patent landscape | Dense hyaluronidase families held by a few companies | Hyaluronidase families not in the path |
| How volume is handled | Larger volumes dispersed by the enzyme, sometimes with on-body devices | A small volume at ultra-high concentration |
| Active ingredients to characterize | Your antibody plus the enzyme | Your antibody only |
| What you launch | An SC copy, once the path is clear | An SC biobetter, now |
05 — Why it's faster
Faster to the clinic, on your terms.
No license to wait for
No enzyme to negotiate for, and no hyaluronidase patent clock to run out.
Your drug substance, as is
Start from the material and analytics you already have for your IV biosimilar.
Feasibility under an MTA
Send us material and get SC feasibility data on your own molecule first.
Clinical supply in-house
Our aseptic GMP line for ultra-high-concentration biologics produces from 2H 2027.
Test your biosimilar now.
Send us your IV drug substance under an MTA. We'll come back with an SC feasibility data package.
General information, not legal advice. Freedom to operate depends on your product, formulation and markets; we review it with you under a CDA.