The association GENEZIS brings together foreign manufacturers of generic drugs and holders of licenses for placing foreign generic drugs on the market.
As of January 17, 2022, the Genesis Association became a member of the International Association of Manufacturers of Generic and Biosimilar Medicines - IGBA https://www.igbamedicines.org/members/igba-members
Info: info@igbamedicines.org
GENEZIS, the Serbian and Montenegrin Generic and Biosimilar Medicines Association, joins IGBA
For immediate release
Geneva, 17 January 2022
IGBA, the International Generic and Biosimilar medicines Association, representing global manufacturers of generic and biosimilar medicines, announced today that GENEZIS has been accepted and welcomed as a new IGBA Associate Member.
GENEZIS is the Association of Generic and Biosimilar Drug Manufacturers for the Republic of Serbia and the Republic of Montenegro representing respectively 14 and 9 generic and biosimilar pharmaceutical manufacturers with a corresponding generics market share of 73,4% and 70%.
GENEZIS also has a strong outreach to Bosnia and Herzegovina, as well as to Macedonia.
“We are very pleased to welcome an association from the Balkans”, commented Vivian Frittelli, IGBA Chair. “One of our goals is to be a representative body for the global generic and biosimilar medicines industries by attracting the widest assembly of members who are committed to subscribing to our standards and common principles and to matching the continuous expansion of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)”. “By welcoming a regional association from the Balkans, IGBA extends its representation in Europe”, he added.
GENEZIS Director, Ana Popović, commented "It is an honour for GENEZIS to participate as a member of IGBA, whose goals we fully share. We are delighted to work together to ensure patient access to affordable, quality, safe and effective medicines and obtain a stronger voice in our region”. “During the most challenging healthcare crises, access to quality-assured, safe and cost-effective
medicines for patients globally is more important than ever, stressed Suzette Kox, IGBA’s Secretary General. “The generic and biosimilar medicines industry is an indispensable part of the global healthcare system. It will continue to play this important role, provided the market and regulatory policies offer the appropriate frameworks”, Kox concluded.
About us: The International Generic and Biosimilar medicines Association (IGBA) strengthens cooperation between associations representing manufacturers of generic and biosimilar medicines from around the world. Adopting a patient centric approach, IGBA works to improve patients’ access to quality-assured, safe and cost-effective medicines by promoting competition and enabling innovation in the pharmaceutical sector and sustainable economic contributions for all stakeholders. For more details, regarding IGBA and its member associations, see the IGBA website at: www.igbamedicines.org.
We are actively participating in the fight against COVID 19.
The association and member companies of the GENEZIS association take care of patients and continuously supply the Serbian and Montenegrin markets.
In Serbia since 2013, in Montenegro since 2017.
Generic drugs are pharmaceutical preparations that contain the same active ingredients in the same concentration as the better-known drugs on the basis of which they were created (the so-called "originator drugs"). Generic drugs differ from originator drugs mostly in the composition of binders and colors, which do not have therapeutic effects and differ by name.
The therapeutic efficacy of generic drugs is equivalent to originator drugs and must be proven by rigorous bioequivalence studies. Which would mean that when scientifically comparing the generic drug and the originator drug, they show the same rate and degree of bioavailability of the active substance in the body if they are administered in the same dose. Simply put, the generic drug and the original product must be equally effective.
The moment when the patent rights of an originator drug expire and when a generic product bioequivalent to it appears, then it is only rational to use generic drugs, because for much less money you can buy an identical product, both therapeutically and in terms of safety. Generic drugs have more affordable prices because they do not require initial basic and clinical research, thus reducing investment. Generic drugs are widely used in EU countries in all treatment programs, and they are increasingly being prescribed by doctors because they are 20-90% cheaper than the originator drugs, so the annual savings from their use are estimated at €35 billion.
The use of generic drugs reduces the costs of each health care system, and the freed funds are used for originator drugs.
Production of generic drugs is carried out according to strict European and international regulations and the highest standards.
All companies that produce generic drugs use ingredients for their products in accordance with the rules of Good Manufacturing Practice (GMP). In short, generic drugs are subject to the same strict standards of quality, safety and efficacy as originator pharmaceutical products.
The aging population and the rapid growth of the treatment of many diseases are putting an additional burden on the sustainability of health care for governments around the world. The cost-effectiveness of using generic drugs provides the fastest growing item in the health budget.
The International and European Association of Generic Drug Manufacturers with its members, cooperates with the Government of countries throughout Europe and the world and develops solutions to improve the availability of generic drugs in order to increase the number of treated patients from the funds of the state fund, which is our goal.
Genesis will also strive for the achievement of general social goals in the production, distribution and application of generic drugs, in order to improve the treatment and health care of the citizens of Serbia, guided by the basic ethical principle - progress in the treatment and prevention of diseases, improving the quality of people's health, the quality of health care and expectations the patient.
Member of the International Generic and Biosimilar medicines Association IGBA
Corporate Compliance Association
