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avalglucosidase alfa-ngpt (Nexviazyme)

avalglucosidase alfa-ngpt is an FDA-licensed reference biologic from Genzyme Corporation. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2021

Reference approved

Reference product

351(a)BLA 761194

Nexviazyme avalglucosidase alfa-ngpt

Genzyme Corporation

Approved
Aug 06, 2021
Marketing
Rx
Center
CDER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for avalglucosidase alfa-ngpt, in chronological order.

  1. Reference approval

    Approval date of the reference avalglucosidase alfa-ngpt product.

    4 yr 11 mo ago

Frequently asked questions

Are there biosimilars approved for avalglucosidase alfa-ngpt (Nexviazyme)?

No 351(k) biosimilars or interchangeable biosimilars referencing avalglucosidase alfa-ngpt are listed in the FDA Purple Book yet.

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