Biologics are a class of medications that are produced from living cells that have had their DNA genetically altered to produce a particular compound, usually a large protein that is used to target a specific disease, as opposed to traditional medications which are just chemically synthesized from non-living material.

What Kinds of Conditions Are Treated With Biological Medicines?

The most severe conditions known are being treated by a biological molecule. These include many forms of cancers such as brain cancer, breast cancer, cancer of the lung, etc. These are major problems for our public health systems and these are being effectively treated by biologics as well as other kinds of very difficult diseases like Rheumatoid Arthritis, Multiple Sclerosis, and the various kinds of anemias. All of these are now being treated by biologic medicines, and that’s roughly about 200 to 300 molecules currently in the biologic world. There are another 400 to 600 that are scheduled to be assessed and researched. These are going to actually treat a much wider array of things, everything from HIV to Parkinson’s disease.

Biologic medicines are made from living cells that have been
genetically engineered to mass produce a specific protein.

What Makes Biological Medicines Different From Other Medicines?

Chemical drugs are produced by a mechanical or chemical process that does not involve the use of living cells. Therefore, chemical drug manufacturing is more predictable and it is easier to get uniform results. Biologics are made from a totally different process. They are made from living cells that have been genetically engineered to mass produce a specific protein. It’s a much larger molecule because it’s made from a living system, and there are a lot more variables that are involved in producing the medication.

What Do These Differences Mean For Patients?

Biologic manufacturers must create an environment for cells to produce exactly the right protein every time. This process helps to ensure that biologic medicines are as uniform as possible, act as intended, and ultimately benefit the patients for whom they are being developed. If they are not done correctly, if the drugs are not tested properly, they are seen as invaders and the body starts to react against the actual biologic drug itself. This can cause an allergic reaction in the patient. The secondary problem that is even worse is that sometimes the immune reaction of the body against these drugs is so great, that it starts reacting against the natural products in the body.

How Are Biologics Tested For Safety?

Biologics actually are very well regulated for safety. For example, a traditional biologics molecule most likely will have to go through between four and five additional tests, compared to a small little molecule. In addition, they also have to go through test-tube testing, animal testing, and then three rounds of clinical trials in human beings. In addition to that, even after the drugs have been approved, there’s something called “Post Market Surveillance.” Drug companies are required to assess the safety of their drugs even after they have been approved.

What Are Biosimilar Medicines And How Do They Differ From Generic Drugs?

Biosimilar Medicines are an effort to try to make good generics out of these very large protein products. In the world of small chemicals, like the pills that we get, these are put into a flask and are spun around, the chemical reaction occurs, and the pills are produced, and literally, generics of these small pills are identical. Biologics are made from living cells and complex biologic systems where there are a lot of other variables that are involved, so is almost impossible to create an exact duplicate of that molecule.

Is There a Way To Know If Biologic or Biosimilar Is a Better Option?

Every situation is different in regards to how patients respond to a particular medication. The only people who are in a position to make this assessment are the physician, and the patient.

What Does The Law Say About Biosimilars, Both From Scientific And Legal Perspectives?

The law permits the FDA to develop guidelines for declaring Biosimilars interchangeable, but the law does not require that the FDA develop any guidelines before it begins approving a Biosimilar as interchangeable. The FDA has the power to say these two drugs are interchangeable, but the difficulty is that we don’t know what the requirements are going to be with respect to how the FDA determines that. Patients and Physicians have to really take note and pay attention to this. Should the FDA decide to develop guidelines, the law requires that the public have an opportunity to provide input.

What Role Will The States Play In How Biosimilars Will Be Used?

First, States may determine whether or not a pharmacist can substitute a Biosimilar for a prescribed Biologic without the consent of a doctor. State laws vary about whether a pharmacist can substitute small synthesized molecule pills without doctor consent. States may need to make new laws and regulations that apply to Biologics, and it is unclear at this point how they will address interchangeable Biosimilars. Another role for States is determining which Biosimilars will be covered under state-sponsored health care plans such as Medicaid.

What Is The Main Takeaway About The Use Of Biologics?

First and foremost, the focus has to be patient safety. It doesn’t matter what the regulatory approaches are, it doesn’t matter what the technology is, safety has to come first. Any rules or laws that are created by the FDA need to be aware of how difficult it is to recreate those systems, and how difficult it is to just substitute another similar type of medication for it. Patients and doctors have a critical role to play in the development of these guidelines, and we will need to make sure that they are the ultimate decision-makers about what treatment options are the most effective, and safest for patients.