Scientific considerations for generic synthetic salmon calcitonin nasal spray products.
Under the Abbreviated New Drug Application pathway, a proposed generic salmon calcitonin nasal spray is required to demonstrate pharmaceutical equivalence and bioequivalence to the brand-name counterpart or the reference listed drug. This review discusses two important aspects of pharmaceutical equivalence for this synthetic peptide nasal spray product. The first aspect is drug substance sameness, in which a proposed generic salmon calcitonin product is required to demonstrate that it contains the same active ingredient as that in the brand-name counterpart. The second aspect is comparability in product- and process-related factors that may influence immunogenicity (i.e., peptide-related impurities, aggregates, formulation, and leachates from the container/closure system). The comparability of these factors helps to ensure the product safety, particularly with respect to immunogenicity. This review also highlights the key features of in vitro and/or in vivo studies for establishing bioequivalence for a solution nasal spray containing a systemically acting salmon calcitonin.
Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, 7519 Standish Place, Rockville, Maryland 20855, USA.
Sau L
SL
Lee
Lawrence X
LX
Yu
Bing
B
Cai
Gibbes R
GR
Johnsons
Amy S
AS
Rosenberg
Barry W
BW
Cherney
Wei
W
Guo
Andre S
AS
Raw
D000280:Administration, Inhalation; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000737:chemistry; D002116:Calcitonin / Q000008:administration & dosage* / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D017277:Drug Approval; D004340:Drug Contamination; D016568:Drugs, Generic; D006801:Humans; D007880:Legislation, Drug; D059085:Nasal Sprays; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
D018927:Anti-Asthmatic Agents; D016568:Drugs, Generic; D059085:Nasal Sprays; C028815:salmon calcitonin; D002116:Calcitonin