Sponsored – Biosimilars: Production to patient | Page 5

efficacy of the drug , as well as to approve the drug ’ s proposed labeling ( package insert ). This process also evaluates the manufacturing process to assure quality , strength , and purity of the drug product .
505 ( b )( 2 ) The Hatch-Waxman Amendments of 1984 were designed to prevent the duplication of existing studies via the creation of the 505 ( b )( 2 ) pathway . A 505 ( b )( 2 ) program is an abbreviated approval pathway that must demonstrate safety and efficacy to the same standards as a 505 ( b )( 1 ) program . However , existing data from studies not conducted by or for the sponsor , and for which the sponsor does not have right of reference , may be used to meet some or all of the safety and efficacy requirements . 20 Often this pathway may be used for situations in which approval is being sought for a new strength or a different formulation ( for example , modified- or delayed release , orally disintegrating tablets , combination medicines ). This usually means a 505 ( b )( 2 ) drug product can be developed with less risk , time , and cost ( if done well ) than a 505 ( b )( 1 ) product . The large variation in types and strategic efficiencies of 505 ( b )( 2 ) development programs creates a large range of time / cost estimates , but all are well below estimates for a 505 ( b )( 1 ) program .
Abbreviated new drug application ( 505 ( j )) The abbreviated new drug application ( ANDA ) is the abbreviated pathway that is used for regulatory approval of generic forms of small molecule drugs . This approval requires a sponsor to demonstrate the same chemical compound and bioequivalence to an innovator drug . In this case , the extensive efficacy and safety studies are not required , which contributes to the ability for generic manufacturers to offer these products at substantial savings to the originator drug product . 21 To be approved , the generic must deliver the same amount of active drug into the patient in the same time as the innovator product . clinical result as the reference product in any given patient ” despite several switches back and forth . To date , there is no product that has been designated interchangeable in the US . The FDA guidance on what is required for the interchangeability designation is relatively new and this is a primary reason why manufacturers have not pursued the interchangeability designation to this point . This status can be achieved by results of post-marketing surveillance and at least one prospective controlled switching study requiring subjects to be switched over at least three times in the switching arm . 17
Interchangeable biosimilar An interchangeable biosimilar is a biosimilar product that has undergone additional switching studies that provide a level of approval that permits substitution with the reference product at the pharmacy level without the intervention of the prescriber . This is similar to what occurs today when generic drugs are routinely substituted for brandname drugs . 18
New drug application ( 505 ( b )( 1 )) pathway Traditional drug development via the 505 ( b )( 1 ) pathway is typically used for novel drugs that have not previously been studied or approved . 19 505 ( b )( 1 ) drug development requires the sponsor to conduct all studies needed to demonstrate the safety and
Biologic license application ( BLA ) ( 351 ( a )) The biologic license application ( BLA ), also referred to as the therapeutic biologics application , is the pathway that is used for regulatory approval of a new biologic entity , including vaccines , blood products , therapeutic proteins , monoclonal
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antibodies , and cellular and genetic therapies . Unlike the NDA used for small molecule drugs , which was created under the Food , Drug and Cosmetic Act , the BLA was created under the Public Health Service Act . Similar to the NDA , a BLA requires the submission of data through the development process that is needed to demonstrate the biologic ’ s efficacy , safety , potency , and purity . It also must include the data necessary to support approval of the indications and drug label .
Biologics Price Competition and Innovation Act ( BPCIA ) This Act was part of the Affordable Care Act that authorized the FDA to develop an abbreviated pathway for approval of biosimilars . The purpose was to allow a regulatory pathway that would permit manufacturers to rely partly on clinical data from an approved reference product in order to create competition and lower costs , similar to what the 1984 Hatch-Waxman Act did for small molecule drugs . This Act , which was signed into law in 2010 , authorized the FDA to create the regulatory pathway for the development of biosimilars and interchangeable biosimilars . 25
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