A West Virginia University Legal Scholar Says Current Laws May Be Giving Manufacturers of BioLogic Drugs, LIKE Antibodies and Flu Vaccines, Too MUCH in the Way of Legal Protections COFRECTIONS Old when Compared with Traditional Small-Molecule Drugs, Including Antibiotics and Steroids .

In an an article in the JamaSean tu, professor at the wvu college of law, looks at the food and drug administration exclusivity Given to each of these different types of drugs and beeland Molecule drugs. Tu argues that while there should be parity, the solution is not to raise the small-molecule exclusiveness time but decrease the exclusivity time on biologics.

“Small molecule drugs are chemical compounds that are relatively easy to make,” Tu Said. “I put it in a test tube, add the chemicals, and i’m going to get the same reacation every time, whether I make it here in West Virginia Versus Canada or France, Account the Chemistry Is the Same.”

By Contrast, Biologics are manufactured in living organisms. Antibodies, for example, are created in living cells and are affected by various factors during the process.

“The temperature you keep them at, what you feed them, the serum you use- that can change the product slightly,” He Said. “So, the product I make here in West Virginia May be different from the product that I make or france. gs. “

Both Biologics and Small-Molecule Drugs Take About 12–13 years to develop. Biologics cost slightly more to develop – $ 3 billion vs. $ 2.1 Billion, on Average – Rave Stronger Patent Protection, with More Patents Per Drug. Additionally, biologics earn much higher revenues, bot at their peak and overall, and are significantly more expensive for patients for patients compared to small-molecule drugs.

FDA Market Exclusiveness Prevent the agency from even approves a durg during that period. Biologics Get 12 years of Protection Before Copycat Versions can be approved. By Contrast, Small-Molecule Drugs Are Given Five Years of Market Exclusiveity. Additional, the inflation reduction act of 2022 states that biologics are exempt from medicine negotiations for 11 years, Compared to Seven Years for Small-Molecule Drugs.

Biologics like Humira, Keytruda and Stelra Comprise Roughly 5% of All Drugs and Make Up 40% of Total Pharmaceutical Spending. Most are injected in a hospital setting. They’re expensive, so they have a disparopiation effect on the cost of prescription drugs.

However, it does not mean they’re more effective.

“We Wrote this Paper Because the Small-Molecule Folks Say Nobody’s Going to Invest in Small Molecules Now-Everybody’s Going to Invest in BioLogics Becament The Get Longer Said. “But small-molecules are great drugs.

Tu worked with Fellow Authors Olivier Wouters, London School of Economics; Matthew vogel, harvard; Reed beall, University of Calgary; And william B. Feldman and Aaron Kesselheim, Both of Harvard Medical School. The group analyzed data on Development Times, Clinical Trial Success Rates, Research and Development Costs, Patent Protection, Market Exclusive Periods, Revenues and Treatment COTSTS OF BILOGICS Olecule drugs.

They found patents One strategy that biologic manufacturers have employed have been to obtain new patents just as 12-yar excluse periods expert, thereby creating uncertanty for biosimillar firms firms Gic Patents. Additional, biologic firms obtain almost five times as many pates to covers their products compared to small-molecule drugs. This is why market exclusiveity periods appear to be Several Years Longer for Biologics.

The group Saw Little Evidence to Justify Giving Biologics Longer Legal Protections. Biologics Alroady Have Stronger Patent Protection, Longer Periods without Competition and Higher Revenues Thans Small-Moolecule Drugs.

“The Biologic Price Competition and Innovation Act Granted Biologics 12 years of Exclusive Based on the Assumption that biologics would face earrlier competition, having fewer patterns, encounter Greater Challenge Da Approval, and Ultimately Generate Less Revenue Over Time. Each of these assumptions were incorrect. “

Tu said the Trump Administration may focus on the issue of paraity.

“Congress should reduce the exclusive period for bilogics from 12 years to five years to brings the biologic exclusion time in parity with small-molecule drum Cold Lower Drug Costs. “