Transition Day for Insulins, Other Products

On Monday, March 23, biologic products formerly evaluated for approval under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) are now approvable only under section 351 of the Public Health Service Act (PHS Act). That means many categories of drugs will now be considered eligible for biosimilar competition.

The transition date was set under the Biologics Price Competition and Innovation Act. Under the European Medicines Agency (EMA), several of these drug categories, including insulin, were already subject to biosimilar approval (in fact, somatostatin was among the first biosimilars to be approved in Europe in 2006). The Table lists all agents affected by the transition. Insulins are the largest (and most significant category) affected by the transition.

According to a statement released by the FDA on March 23, “Today is a milestone for the future of insulin and other important treatments—potentially a new era of proposed biosimilar and interchangeable insulin products. We expect this regulatory transition to enable a vibrant competitive market for transitioning products, ultimately empowering patients by increasing choices and potentially lowering prices of safe, effective, high-quality medications.”

As reported previously in BR&R, the transition has been a long time in coming and had to address several hurdles. Whereas the FDA is hopeful that opening biologics like insulin to biosimilar competition will help lower prices and widen availability, few manufacturers have publicly stepped up to the plate and announced their plans to develop insulin biosimilars.

TABLE: DRUGS AFFECTED BY THE TRANSITION TO 351(K) BIOLOGIC STATUS

Nonproprietary Name Proprietary Name NDA Holder Initial Date(s) of Approval
aprotinin   Trasylol Bayer HealthCare Pharmaceuticals Inc. 12/29/1993
beractant  Survanta AbbVie Inc. 07/01/1991
calfactant Infasurf ONY INC 07/01/1998
choriogonadotropin alfa  (Multiple) (Multiple) Before 09/20/2000
desirudin  Iprivask Valeant Pharmaceuticals North America LLC 04/04/2003
fibrinolysin and desoxyribonuclease combined [bovine], with chloramphenicol Lasechloromycetin Pfizer, Inc. 04/01/1964
follitropin alfa Gonal-F
Gonal-F RFF Gonal-F RFF Redi-Ject
EMD Serono, Inc. 09/29/1997, 03/25/2004, 05/25/2004
follitropin beta and follicle-stimulating hormone Follistim, Follistim AQ   Organon USA Inc, a subsidiary of Merck & Co 09/29/1997 08/26/2005
hyaluronidase  Amphadase Amphastar Pharmaceuticals, Inc. 10/26/2004
hyaluronidase  Hydase Akorn, Inc. 10/25/2005
hyaluronidase  Hylenex Halozyme Therapeutics, Inc. 12/02/2005
hyaluronidase  Vitrase  Bausch & Lomb Incorporated 05/05/2004
imiglucerase  Cerezyme Genzyme Corporation 05/23/1994
insulin aspart  Novolog, Fiasp Novo Nordisk Inc. 06/07/2000, 09/29/2017
insulin aspart protamine and insulin aspart Novolog Mix 50/50, Novolog Mix 70/30 Novo Nordisk Inc. 08/26/2008, 11/01/2001
insulin degludec  Tresiba  Novo Nordisk Inc. 09/25/2015
insulin degludec and insulin aspart  Ryzodeg 70/30 Novo Nordisk Inc. 09/25/2015
insulin degludec and liraglutide  Xultophy100/3.6 Novo Nordisk Inc. 11/21/2016
insulin detemir Levemir Novo Nordisk Inc. 06/16/2005 and 10/19/2005
insulin glargine  Basaglar  Eli Lilly and Company 12/16/2015
insulin glargine  Lantus, Toujeo Sanofi-Aventis US LLC 04/20/2000, 02/25/2015
insulin glargine and lixisenatide  Soliqua Sanofi-Aventis US LLC 11/21/2016
insulin glulisine  Apidra Sanofi-Aventis US LLC 04/16/2004
insulin human  Afrezza Mannkind Corporation 06/27/2014
insulin human  Humulin R
U-500 and U-100
Eli Lilly and Company 10/28/1982
insulin human Myxredlin Celerity Pharmaceuticals LLC 06/20/2019
human insulin isophane  Humulin N Eli Lilly and Company 10/28/1982
human insulin isophane and human insulin Humulin 70/30 Eli Lilly and Company 04/25/1989
NPH, human insulin isophane Novolin N Novo Nordisk Inc. 07/01/1991
NPH, human insulin isophane and regular, human insulin Novolin 70/30 Novo Nordisk Inc. 06/25/1991
regular, human insulin  Novolin R Novo Nordisk Inc. 06/25/1991
insulin lispro  Humalog Eli Lilly and Company 06/14/1996 and 05/26/2015
insulin lispro Admelog Sanofi-Aventis US LLC 12/11/2017
insulin lispro protamine and insulin lispro Humalog Mix 50/50, Humalog Mix 75/25 Eli Lilly and Company 12/22/1999  
iodinated 1-125 albumin  Jeanatope, Megatope Iso Tex Diagnostics Inc 02/23/1976
albumin chromated CR-51 serum Chromalbin  Iso Tex Diagnostics Inc 02/23/1976
kit for the preparation of technetium tc-99m albumin aggregated  (Multiple) (Multiple) Before 01/1/1988
radiolabeled albumin technetium tc-99m albumin colloid kit Microlite  Pharmalucence Inc 03/25/1983
lixisenatide Adlyxin Sanofi-Aventis US LLC 07/27/2016
mecasermin  Increlex Ipsen Biopharmaceuticals, Inc. 08/30/2005
mecasermin rinfabate  Iplex Insmed Incorporated 12/12/2005 
menotropins Humegon  Organon USA Inc, a subsidiary of Merck & Co 09/01/1994
menotropins Repronex, Menopur Ferring Pharmaceuticals Inc, 08/27/1999, 10/29/2004
menotropins Pergonal EMD Serono, Inc. 08/22/1975
pancrelipase  Creon AbbVie Inc. 04/30/2009
pancrelipase (multiple) (multiple) Before 05/18/2012
pegademase bovine   Adagen Leadiant Biosciences, Inc. 03/21/1990
pegvisomant  Somavert Pharmacia & Upjohn Company 03/25/2003
poractant alfa Curosurf Chiesi USA, Inc. 11/18/1999
sacrosidase Sucraid QOL Medical, LLC 04/09/1998
somatropin   (multiple) (multiple) Before 01/24/2008
taliglucerase alfa  Elelyso Pfizer Inc. 05/01/2012
tesamorelin acetate Egrifta SV Theratechnologies Inc. 11/10/2010
thyrotropin alfa  Thyrogen Genzyme Corporation 11/30/1998
urofollitropin  Bravelle  Ferring Pharmaceuticals Inc. 05/06/2012 12/19/2002
urokinase  Kinlytic Microbix Biosystems Inc. 01/16/1978
velaglucerase alfa VPRIV Shire Human Genetic Therapies, Inc. 02/26/2010

NDA = New drug approval. Source: Food and Drug Administration.

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