Hyaluronidase, rDNA
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Hylenex; Enhanze SC; Cumulase; rHuPH20; Chemophase; PH-20 hyaluronidase, recombinant human
Status: approved and marketed in U.S. and EU
Organizations involved:
Halozyme Therapeutics, Inc. – Manuf.; R&D; Tech
Baxter Healthcare Corp. – USA mark.; Europe mark.; Parent
Baxter Pharm. Solutions LLC – Manuf. other
MidAtlantic Diagnostics, Inc. – World mark.
MediCult A/S – World mark;
Hoffmann-La Roche Ltd. – R&D; World mark.
Avid Bioservices, Inc. – Manuf.
Cook Pharmica LLC – Manuf.
Peregrine Pharmaceuticals Inc. – Parent
University of Connecticut – R&D; Tech.
ProMetic Life Sciences Inc. – Tech.
Sidney Kimmel Cancer Center – Former
ProMetic Life Sciences Inc. – Manuf. other
Cross ref.: See the other hyaluronidase entries, e.g., Wydase (#616) and Amphadase (#617), in the Enzymes section for background information and about currently marketed bovine and ovine hyaluronidase products.
Description: Hylenex (formerly Enhanze SC) is an injectable aqueous formulation and Cumulase is an ex vivo reagent/medical device, both containing soluble recombinant fragment (amino acids 36-482) of PH-20 human hyaluronidase (rHuPH20) glycoprotein expressed by transformed Chilnese
... truncated (just the beginning)
Annual sales (2008; $million): (reserved for subscribers)
Annual sales (2009; $million): (reserved for subscribers)
Annual sales (2010; $million): (reserved for subscribers)
Annual sales (2011; $million): (reserved for subscribers)
Annual sales (2012; $million): (reserved for subscribers)
Index Terms:
Companies involvement:
Partial monograph text:
186 Hyaluronidase, rDNA
Nomenclature:
Hyaluronidase, rDNA [BIO]
Cumulase [TR]
SynVitro Cumulase [TR]
Enhanze SC [TR former]
hyaluronidase human injection [FDA]
hyaluronidase (human recombinant) [USAN]
36-482-hyaluronoglucosaminidase PH20 (human) [CAS]
hyaluronidase 1 (human sperm surface protein PH-20)-(1-447)peptide [CAS]
57971-58-7 [CAS RN]
hyaluronidase PH-20, recombinant human [SY]
PH-20 hyaluronidase [SY]
rHuPH20 [SY]
E.C. 3.1.25 [EC]
NDC 60977-319-03 [NDC]
molecular weight (kDa) = 61
FDA Class: Drug NDA biogeneric follow-on protein 505(b)(2)
Year of approval (FDA) = 2005
Annual sales (2007; $million): (reserved for subscribers)
Biosimilars/biobetters Data
U.S.A.
European Union (EU)
Biosimilars/biobetters-related U.S. Patents: Reserved for subscribers]
U.S. Patent Expiration Year: Reserved for subscribers
U.S. Biosimilars Data Exclusivity Expiration: Reserved for subscribers
U.S. Biosimilars Orphan Exclusivity Expiration: Reserved for subscribers
U.S. Biosimilars Launchability Year: Reserved for subscribers
U.S. Biobetters Launchability Year: Reserved for subscribers
Biosimilars/biobetters-related EU Patents: Reserved for subscribers
EU Patent Expiration Year: Reserved for subscribers
EU Biosimilars Data Exclusivity Expiration: Reserved for subscribers
EU Biosimilars Orphan Exclusivity Expiration: Reserved for subscribers
EU Biosimilars Launchability Year: Reserved for subscribers
EU Biobetters Launchability Year: Reserved for subscribers
biopharmaceutical products
Biorex-70 resin
enzymes
exempt from CBER lot release requirements
hamster source materials
human materials used<!-- humansource -->
recombinant DNA
Chinese hamster ovary (CHO) cells
Dynabeads
fusion protein, proinsulin-tryptophan synthetase
hyaluronidase
maltose
adw, hepatitis B virus subtype
Albumin (Human)
ampicillin
Hy-Case SF
4D5 murine hybridoma cells
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
approval dates uncertain (FDA reports erroneous, conflicting, or simply has lost the original approval dates) (FDAapproved)
BHK-21 (C-13)
EU200 Currently Approved in EU
UM001 Marketed Product in US
US200 Currently Approved in US US777
EM001 Marketed Product in EU
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