Generic Pharmaceuticals

A generic product is the bioequivalent of a pharmaceutical originator product that has already been on the market for several years.

In most countries, new pharmaceuticals enjoy patent protection
for a period of 20 years. When the patent expires, other companies
holding the appropriate licenses are entitled to manufacture and
market the pharmaceutical, provided they comply with the applicable
laws and regulations.

A generic pharmaceutical contains the same active substances as
the originator product. Once therapeutic bioequivalence has been
established, the generic product is substitutable for the
originator product.

Generic medicines offer the same quality and safety profiles as
the originator products. Throughout their development and
production processes, generics must adhere to the same rigorous
standards of quality, safety and efficacy as the originator
products. These standards are closely monitored and enforced by the
relevant regulatory authorities both prior to and after product
approval. Manufacturing plants are regularly inspected to ensure
that they remain cGMP-compliant (current Good Manufacturing
Practice), while products on the market are regularly monitored to
ensure they continue to meet the quality standards.

The Role of Generics in Society
  • Competition is increased and production costs fall, allowing
    for profitability while lowering prices to the consumers
  • Patients obtain increased access to high quality, safe and
    effective medicines
  • Allow for significant savings for both patients and healthcare
    systems
  • More cost-efficient treatment releases resources for new
    innovative treatments or medicines
  • Provide and incentive for companies which produce original
    pharmaceuticals to continue to develop innovative

Development

Product Development

Contact us

Bluefish Pharmaceuticals AB
Gävlegatan 22
SE-113 30 Stockholm
Sweden
Tel: +46 8 5191 1600
Fax: +46 8 5191 1690
info-se@bluefishpharma.com