What Is an Abbreviated New Drug Submission (ANDS)?
An Abbreviated New Drug Submission (ANDS) is a written request to Health Canada to obtain marketing approval for a generic drug. An Abbreviated New Drug Submission must be approved by Health Canada, the country’s federal department in charge of national health care, under Canada’s Food and Drug Regulations, before the generic drug can be marketed in the country. An ANDS provides the necessary information for the government agency to evaluate how safe and effective a generic drug is compared with its brand name equivalent. The generic drug must be equally safe and effective to gain approval.
Understanding Abbreviated New Drug Submissions (ANDSs)
An Abbreviated New Drug Submission is used to obtain approval for generic drugs. This is in contrast to a New Drug Submission (NDS), which is used to obtain approval for a new brand name drug. An ANDS lists the related drug’s brand name, chemical name, manufacturer name, dosage form(s), and strength(s). It states whether the drug has already been approved for marketing in the United States, the European Union, Switzerland, Singapore, and/or Australia. It also addresses questions about drug impurities and drug stability.
- An ANDS is required to obtain marketing approval for generic drugs in Canada.
- The submission provides critical information, such as data on studies comparing the generic drug to the approved brand name drug and their respective bioavailabilities.
- The number of approved ANDS applications can be a data point for investors in biotechnology to determine a pharma company's profit potential.
Generic drugs are biologically equivalent to the brand name drugs on which they are based. They are comparable in dosage form, strength, route of administration, quality, performance characteristics, and intended use. They are designated "abbreviated" because preclinical and clinical data are not required to establish their safety and efficacy.
An ANDS supplies information regarding data on studies comparing the proposed drug to the approved brand name drug, called the “reference drug,” and asks for data from studies conducted on the generic drug. For example, for drugs with delivery devices, the ANDS states whether there have been studies comparing the physical and operating characteristics of the brand name device with those of the proposed generic device. For tablets, it states whether the proposed generic drug has been scored like the brand name so the generic tablet can be divided similarly to the brand name tablet. The ANDS also supplies information about studies comparing the bioavailability of the brand name drug with that of the proposed generic drug, and about the results of bacterial endotoxin tests for sterile drugs. The applicant must pay a fee in conjunction with its ANDS.
ANDSs and Biotechnology Investments
One way for investors to evaluate biotechnology companies is to examine their pipeline of ANDSs. A company with a high number of pending ANDSs relative to its competitors may end up with more generic drugs to sell and therefore be more profitable. Pharma companies may also purchase ANDS applications from other firms in order to develop their own pipeline.