Generics are part of a strong medicine pipeline

Beef 911: The regulatory regime, including patents, means the product lineup is always changing

Generic medicines have been around for a long time in both human and animal medicine.

They are essentially copycat products that come out after the protective patents run out on the original product. You are familiar with the ‘apo’ products that are available when you get your human prescriptions filled and it is really no different in veterinary medicine.

Some pharmaceutical companies have a great many of these products and others are the ones that more invent, research and license the original product (although all companies have some generic products or acquired ones). A few others may bring back discontinued products. Some amount of licensing and testing still has to be done but the bulk of the work has already been done.

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I’m often asked, why is Product A no longer being made as it worked really well and was effective? Often it is simply dollars and cents — the amount of sales doesn’t warrant keeping the product around. This, for example, happened with some of the products to treat coccidiosis as with better prevention protocols and management, as well as manure control, the number of cases dropped off dramatically. This is good for the cattle industry but if you do need that specific product it is frustrating that it is no longer available. Sometimes, old products may require updated testing on efficacy or safety, and economically it doesn’t pay. Regulatory practices can make it just cost prohibitive to keep it on the market.

When a product is registered after all the preliminary testing for safety, efficacy and withdrawals are determined, the time starts ticking. The patent essentially is for about 17 years but I believe that is from the time of first approval. To get testing and withdrawals checked and labelling designated and approved may take several years. It can take a long time for a company to get its huge research and licensing costs back. As well, initially hundreds, if not thousands, of products are screened to come up with the potential product with most rejected prior to licensure for again safety, efficacy, difficulty in manufacture stability and many, many other reasons.

With generics one already has the exact chemical formulation of the product, but still some testing is needed to appease the regulatory authorities as to requirements of manufacturing and get the label approved. Sometimes the label will be word for word from the original label and other times companies shortcut and leave some of the label claims off as they may be a minor or seldom used claim, or for a minor species.

This is why many minor species such as sheep, goats, bison or elk are not on the label as each species (or even specific group within a species such as veal calves) takes additional testing to get it on the label. This is all done in the best interests of human and animal safety as well as food safety when it comes to things such as residues in milk.

Other times, generic products may be an improvement over the original. It may even be soft things — such as dispensed in a plastic bottle, the glass bottle comes protected from breakage, or comes with a dispensing syringe, or be more syringeable. These attributes all may help to get more market share. Keep in mind all these changes themselves need to get approved by the regulatory bodies.

When popular products come off patent, it is not uncommon to over time have one or more generic look-alikes. Again, labelling may be slightly different but effectiveness (efficacy), syringeability, method of administration, and slaughter or milk withdrawal time (if applicable) should all be very similar to the original product.

Again, if the testing was not done on, for example, milk withdrawal, then it will not appear on the label. Your veterinarian and you should be aware of that. With more products, price generally will come down and that is what an open market does. Most pharma companies will have some generic products in their portfolio.

Your herd veterinarian will then have the ability to change between products based on availability, price, size of the bottle or the fact that they deal more with a specific pharmaceutical company. There may be loyalty based on service, education, personnel, perceived ethics of a company and a past history with the pharma company and its field reps.

These are all good things for you and your cattle’s health going forward. We have probably almost reached the minimum number of large pharma companies, otherwise monopolistic conditions arise. Competition is healthy and leads to improved products.

Large pharma puts a tremendous amount of money into research to develop more effective and new vaccines, antimicrobials and other products including equipment that will keep our cattle healthy. You can count on more and more change going forward and innovation in the pharmaceutical industry. The recent COVID-19 outbreak is a perfect example of how important pharma is to the well-being of the world.

Behind the scenes new vaccines are always being developed in both human and animal pharma to ensure our health, animal health, bio­security and food safety.

About the author

Columnist

Roy Lewis practised large-animal veterinary medicine for more than 30 years and now works part time as a technical services veterinarian for Merck Animal Health.

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