Alvotech has resubmitted a Biologics License Application (BLA) for AVT06, its proposed biosimilar to Regeneron Pharmaceuticals, Inc’s EYLEA 2 mg (aflibercept).
I’m not familiar with this company …
Well, then—a refresh is in order.
Founded in 2013 and headquartered in Reykjavik, Iceland, the global biotech company specializes in developing, manufacturing—within its on-site manufacturing facility as well as four production sites across Europe—and commercializing biosimilars.
Its current pipeline is reported to encompass eight biosimilar candidates addressing: autoimmune disorders, eye disorders (our focus), osteoporosis, and cancer.
And its investigational biosimilar?
As we mentioned, AVT06 is a proposed biosimilar for the FDA-approved EYLEA, a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of five retinal diseases:
- Wet age-related macular degeneration (AMD)
- Diabetic retinopathy (DR)
- Diabetic macular edema (DME)
- Macular edema following retinal vein occlusion (RVO)
- Retinopathy of prematurity (ROP)
To note: Alvotech has partnered with the U.S.-based Teva Pharmaceutical Industries Ltd. on AVT06’s development and manufacturing (Alvotech’s responsibility) as well as commercialization (which will fall to Tevo).
Talk about EYLEA biosimilars for a moment.
Regeneron and Bayer AG, its commercialization partner for EYLEA, have filed numerous patient infringement lawsuits over the last few years against biotech companies seeking to push out their own biosimilars.
In regards to Alvotech: The company (and Teva) reached a settlement and license agreement with Regeneron and Bayer in December 2025 granting them a license entry date for AVT06 (pending the FDA’s BLA approval, of course) in the United States.
That date: Q4 2026 (or earlier, depending on certain circumstances).
Alrighty, so what’s the situation that led to this BLA resubmission?
The FDA first accepted Alotech and Teva’s initial BLA filing in February 2025 after the duo submitted the biosimilar’s application package the month prior.
- See here for the positive topline data (from this confirmatory study on wet AMD) included in the submission.
Fast forward to June-July 2025: The FDA conducted a pre-approval inspection (PAI) of Alvotech’s Reykjavik manufacturing facility for the BLA (along with two others the company submitted).
And the outcomes from that?
A Form 483 was issued to to the company shortly after in which the agency outlined observations of:
- Deficiencies in certain manufacturing operations and controls
- Instances of certain quality procedures not being followed
- Deficiencies in some documentation practices, laboratory controls, and materials management procedures
Alvotech responded to the FDA in late July 2025, saying that it intended to “fully address all observational topics identified.”
So then what happened?
Skipping ahead to November 2025: The FDA sent Alvotech a complete response letter (CRL) regarding AVT06 in which those aforementioned facility inspection deficiencies were cited.
However, in sharing this development in its Q4 2025 report, the company expressed confidence in its already-initiated plan to address the issues.
- “(We are) well-positioned to resubmit the BLAs and progress toward U.S. approval as soon as the facility issues are resolved,” Alvotech stated.
And more recently?
Last month, Alvotech announced the FDA had completed a routine current Good and Manufacturing Practice (cGMP) surveillance inspection of its Reyjkavik manufacturing facility.
Post-inspection: The company was sent (another) Form 483 in early May—with Alvotech saying at the time that it “believes the observations can be addressed quickly and do not raise substantial issues with the site or its operations.”
I take it those issues were addressed, given this BLA resubmission news.
Indeed. See here for the steps the company took to resolve them.
Now, what’s the updated timeframe for an FDA decision?
Avotech is anticipating a 6-month review period—so likely the end of 2026 (right on target with that license entry date settlement we mentioned earlier).
If approved, this would become the sixth EYLEA biosimilar (two are designated as interchangeable, and four are not).