Generic vs Branded Drugs
Everyone wants to have drugs for all indications and these drugs need to be proven safe by thorough testing both preclinically and in clinical studies and everyone wants the drugs to be affordable. In a perfect world, this would still be a difficult task to accomplish. What is the best way to provide affordable alternatives to popular pharmaceutical therapies of today?
Generic pharmaceuticals, or previously marketed therapies, are the answer. I have spent a significant amount of my industry career around generic drug manufacturing and have full confidence in the products.
According to the FDA, a generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics.
Generic drugs are a less expensive version of the brand medication. The brand drug has enjoyed patent protection for years to enable the pharmaceutical company to recoup costs of development of that drug. Once generic drugs are allowed to compete with the brand drugs, both are available, and the consumer has a choice. The price of the brand drug inevitably comes down to compete with the generic version.
FDA Statement on Access to High-Quality, Low-Cost Generic Drugs
Norman E. “Ned” Sharpless MD, Acting Commissioner of Food and Drugs – Food and Drug Administration
Affordable access to medicines is a public health concern and more generic drug competition can help reduce prices, improve access and benefit the public health. Safe, effective and high-quality generic drugs play a vital role in our health care system. Generic drugs account for about 90% of all prescription drug purchases in the U.S. In 2018, competition from generic drugs saved the health care system about $293 billion.
For year 2019 figures overall show a total of 1,171 generic drug approvals (935 full approvals and 236 tentative approvals). This breaks our all-time record of 971 for fiscal year 2018. Additionally, in year 2019 we approved 125 applications for first generics of medicines that had no generic competition. First generics approved in fiscal year 2019 included an emergency opioid overdose treatment and drugs to treat conditions such as pulmonary arterial hypertension, breast cancer, seizures, depression and various infections.
Consumers must also have confidence in the safety and quality of generic medicines. The FDA’s scientific review and assessment process for generic drug applications ensures that generic medications perform the same way in the human body, have the same active ingredients and have the same conditions of use as their counterpart name brand medication. Generic drugs are held to high approval and manufacturing standards and once a generic medication is approved, the FDA continues to monitor its safety, effectiveness and quality, including through periodic inspections of manufacturing plants, careful evaluation of post-approval changes proposed by manufacturers and thorough assessment of any adverse event reports. Just like branded drug monitoring processes.
The whole article can be found at this link: https://www.americanpharmaceuticalreview.com/2727-Blog/518728-FDA-Statement-on-Access-to-High-Quality-Low-Cost-Generic-Drugs/
Top 10 Generic Drug Manufactures and their recent earnings:
- Sanofi $1.69bn
- Dr. Reddy’s $1.74bn
- Sawai Pharmaceutical $1.77bn
- Hikma Pharmaceuticals $1.8bn
- Cipla $2.2bn
- Lupin $2.27bn
- Sun Pharmaceutical Industries $4.11bn
- Teva Pharmaceutical $9.67bn
- Sandoz $9.85bn
- Mylan $11.26bn
These are global companies that compete against each other and the branded pharmaceutical companies every day. These companies are headquartered all over the world and they sell product all over the world.
Generic companies sell their products with slimmer margins and must be more cost effective to compete and survive. The process of generic drug development has multiple points where Superior Toxicology & Wellness can provide a more cost-effective solutions for a generic pharmaceutical company. These solutions are described in our services menu, and it is our highest priority to help meet your needs. The excellent value of Superior Toxicology & Wellness products is complemented by our extremely quick turnaround and first-class customer service.
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We look forward to hearing from you soon on how we can help assist your company.
Dr. Joe Nieusma and the Superior Toxicology & Wellness Team