You need a swift response to any disease outbreak in your herd to stem the spread and avoid delays in getting your animals to market. Here are five things to understand about generic animal health products when deciding how to treat your cattle.
1. Brush up on bioequivalence.
According to the FDA, a generic product can be defined as bioequivalent to the pioneer drug when it contains the exact same active and inactive ingredients (including carriers and excipients) and is also the same strength, dosage form and route of administration as the pioneer product. If considered bioequivalent, the generic drug is granted the same label claims as the pioneer product.
2. Separate myth from fact about generic products.
“Some people think generic products may not be as good,” said Dr. Chris Thomsen, senior technical services veterinarian with Bimeda. With their U.S. headquarters based in Oakbrook Terrace, Illinois, Bimeda is a leading global manufacturer, marketer and distributor of animal health products and veterinary pharmaceuticals that is established in over 80 countries worldwide.
Thomsen said some misconceptions about generic products persist — the false belief that they contain a lower concentration of an active ingredient or different non-active components that affect the products quality than a pioneer drug or the fallacy that generic manufacturing processes are less stringent.
A veterinarian who has worked with cattle for 23 years, Thomsen dispels myths about generics by providing accurate information. “There really are no risks with generics because the ingredients are the same,” he said.
Thomsen also noted the FDA inspects the facilities where generics are manufactured. “Of course, all FDA approved plants have to have good manufacturing processes and quality control standards in place, as the FDA doesn’t differentiate manufacturing standards between a facility that manufactures pioneer or generic products. They recognize each plant to have the same standards. Most plants like Bimeda manufacture generic and pioneer in the same plant,” he said.
3. Look for a generic product with data that substantiates its effectiveness.
Following the patent expiration of Zoetis’ Draxxin® (tulathromycin injection) — the highest selling cattle antibiotic in the U.S. — in February of 2021 Bimeda® was the first company to launch a bioequivalent generic product into the market. Bimeda’s product, named Macrosyn® (tulathromycin injection), was granted the same label claims as the pioneer product by the FDA and it is approved for the treatment and control of bovine respiratory disease (BRD) and the treatment of bovine foot rot and pinkeye. Since Macrosyn’s launch, several more companies have launched generic tulathromycin products into the market but, to date, Bimeda is the only generic manufacturer that has proven its equivalence to the pioneer product in a large-scale field trial.
In 2022, Bimeda published the results of a large-scale randomized block design study involving 4,685 moderate- to high-risk steers treated for bovine respiratory disease. That study showed that Macrosyn is no different from the pioneer drug, producing equal results in controlling the disease. To further document the effectiveness of Macrosyn, Bimeda conducted a second large-scale study, this one with dairy calves. The additional study also compared Macrosyn to the pioneer version of tulathromycin injection in treating and controlling bovine respiratory disease.
“The second study proved once again that there are absolutely no differences between Macrosyn and the pioneer drug,” Thomsen said. Bimeda will publish a technical bulletin with data from the second study later this year.
4. Choose a generic backed by customer service.
“Some manufacturers don’t have anybody in the field,” Thomsen said. “They just throw the product out there and say, ‘Here you go.’” In contrast, Bimeda provides extensive customer service, including sending experienced sales representatives and technical service veterinarians to visit ranchers and veterinarians to help solve any issues they may be having with their herds. “We also have a customer service number that people can call with questions,” he said. “We are always talking to customers and helping them solve problems.”
5. Enlist your local vet to help evaluate generic products.
Ranchers know that treating cattle early with the right antibiotic increases the likelihood of full recovery without lingering illness. “Local vets are really good at recommending products and treatment protocols,” Thomsen said.
Bimeda’s customer service often includes involving a local vet to help ranchers investigate issues with their herds. For instance, if a rancher thinks his animals are not responding to treatment as well as they should be, Bimeda will assist in finding out why, often bringing a local vet into the loop for investigation and diagnostics.
With the field trial work that has been completed to date, highest market share out of all the FDA-approved generic tulathromycin products and full-scale customer support, Bimeda is the resource ranchers can rely on in managing healthy herds. “We’re here to help cattle producers be profitable so they can maintain what they do, which is raising food for all of us,” Thomsen said.
For more information, visit macrosyn.com.
