The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

FDA’s approval letter went out on October 28, 1982, for recombinant human insulin (HUMULIN-R). FDA Endocrine Division Director Dr. Sol Sobel signed the letter.

While prescription drugs are approved via an NDA under Section 505 of the FFDCA, biologics are licensed via a biologics license application (BLA) under Section 351 of the PHSA. The exception to this is certain natural source biologics regulated as drugs under the FFDCA (e.g., insulin).

CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER also provides the public with information to promote the safe and appropriate use of biological products.

Whereas a new drug application (NDA) is used for drugs subject to the drug approval provisions of the FDC Act, a biologics license application (BLA) is required for biological products subject to licensure under the PHS Act. FDA approval to market a biologic is granted by issuance of a biologics license.

What is a biological product? Biological products are regulated by the Food and Drug Administration (FDA) and are used to diagnose, prevent, treat, and cure diseases and medical conditions. Biological products are a diverse category of products and are generally large, complex molecules.

A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.

Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

Specifically, industrial biotechnology uses enzymes and micro-organisms to make bio-based products in sectors such as chemicals, food ingredients, detergents, paper, textiles and biofuels.

With the exception of efalizumab, which has been withdrawn from both the European and U.S. markets due to long-term safety concerns, these biologics are generally well tolerated in long-term studies, and offer a viable alternative to conventional non-biologic agents in patients with moderate-to-severe plaque psoriasis.

Biologics Stem From Live Cells The strictest definition says biologic drugs only come from living systems or contain organic molecules, whereas small-molecule pharmaceuticals largely come from chemicals. Often, biologics are injected. If it’s swallowed, it’s probably not a biologic drug.

Patients with plaque psoriasis taking apremilast, etanercept, and ustekinumab had a lower rate of serious infections than those who took methotrexate.

Common side effects of biologic drugs include: Allergic reactions. Injection site reactions. Chills….Serious side effects of biologic drugs include:

• Low blood pressure.
• Anaphylaxis.
• Serious infections.
• Cancer.
• Serum sickness.
• Autoimmune thyroiditis.
• Arterial and venous blood clots.
• Congestive heart failure.

Biologic therapies (both first and second generation) cannot be made using a simple chemical reaction, such as mixing ingredients together in a laboratory, the way conventional drugs are made. Instead, biologic therapies are made using living organisms, such as bacteria, yeast, and even mammalian tissue and cells.

Risk of Infection All biologics suppress the immune system and increase the risk of infections. Common infections. People who take biologics are morel likely to get infections such as upper respiratory infections, pneumonia, urinary tract infections, and skin infections.

Biologics reduce the risks of premature death, increased heart disease and the need for joint surgery. Patients with uncontrolled RA are also at higher risk of infection, so controlling the arthritis can also reduce overall infection risk. On balance, you are much better off with treated disease than untreated.

However, these medications come with side effects including reduced ability to fight infection. They require a subcutaneous injection or intravenous infusion. You should continue taking your biologic even while in remission, unless instructed otherwise by your doctor.

The cheapest biosimilars are Kanjinti and Ogivri, which are both 15% cheaper than Herceptin for a 150 mg vial. Herzuma, which was approved in 2018, has only a 10% discount compared to Herceptin.

HUMIRA and methotrexate—five times more effective at slowing the progression of joint damage. In the same study, the combination of HUMIRA and methotrexate, on average, was 5 times more effective at slowing the progression of joint damage than methotrexate alone after 2 years.