Patents and Generic Biologic Drugs- Part III of a III Part Series

We are separating the article on generic biologic drugs from the articles on patents on brand name drugs, since changes under the new health care law (Patient Protection and Affordable Care Act of 2010) allow for generic biologics.

(11/21/19)- A recent review by the Wall Street Journal of records from the Food and Drug Administration (FDA) found that only 11 generic  biosimilar drugs are available, even though over two dozen had been approved since 2015.

The main cause for the delay in the marketing of these drugs was caused by the pharmaceutical companies bringing patent infringement suits against the generic companies. These suits often resulted in a settlement being reached where the generic company received a payment from the holder of the expired patent to either delay or even postpone the sale of the generic biosimilar drug

(7/27/17)- Samsung Bioepis Co., the pharmaceutical subsidiary of Samsung, the South Korean conglomerate became the second company to sell a generic biosimilar drug to Johnson & Johnson’s best-selling rheumatoid arthritis drug Remicade. The Samsung drug, known as Renflexis will be marketed by Merck and Co., and it will sell at about a 35% discount to Remicade’s current list price of $1,100, or $30,000 for a year’s treatment.

Remicade had sales of about $5.2 billion in the U.S. last year, making it the company’s best-selling drug, with its oncology drug Zytiga totaling $1.698 billion is sales in 2016 (

 A spokesman for J&J said that, with discounts, Remicade costs about $800 per vial.

Merck & Co., which has rights to sell Remicade in Europe, Russia and Turkey garnered $2.27 billion in sales in 2016

Hospira., and its partner Celltrion Inc. launched the first generic biosimilar copy of Remicade in Nov., 2016, and it sold at about a 15% discount to the J&J drug. The Hospira-Celltronr version of Remicade is called Inflectra.

 (5/9/16)- It looks like generic biologic drugs are not going to save the consumer much because of the fact that the price of the drug is being increased a lot before it comes off patent.

Humira, the best-selling rheumatoid arthritis drug from AbbVie whose patent is due to expire on December 31 has had its list price increase 8 times, by a total of 73% in the last 8 years.. When the biosimilar generic version of the drug comes on the scene it is expected to sell at only a 15% discount to the price Humira was last selling at.

Spending on biosimilar drugs has nearly doubled in the last 5 years to $128.7 billion is 2015, and accounted for 54% of the increase in prescription drug spending since 2010, according to IMS Heath, the medical-data consulting firm.

The first biosimilar drug to come to market in the U.S. was the biosimilar for Amgen’s Neupogen for cancer patients. Amgen increased the list price of the drug three times in the 3 years before the patent on it expired. The biosimilar drug was priced only 15% lower than the original, according to Truven Health Analytics.

(7/24/15)- The U.S. Court of Appeals for the Federal Circuit in Washington ruled that Novartis AG could begin the first U.S. sales of their biosimilar drug Zarxio in competition with Amgen Inc.s drug Neupogen. Neupogen is given to chemotherapy patients whose immune system has been weakened through chemo or radiation therapy. Please see our item dated 3/9/15 below for further info on this matter.

The Affordable Care Act of 2010 (ACA) allowed generic versions for biosimilar drugs after a 12 year patent expiration timeframe. Unlike regular drugs which are copied by generic manufacturers when a patent expires, biosimilar drugs are created through cell growths and thus may not be exactly the same as the chemical drug in composition.

Neupogen had $839 million in sales last year. The Food and Drug Administration had approved Zarixo for sale in March, 2015, but Amgen has been trying to prevent Novartis from selling the drug by arguing in the federal courts that Novartis failed to follow the timing and notification terms set under the ACA.

Amgen has not stated whether it would appeal this ruling or take further action on a related patent infringement case it has filed which is still pending.

(3/9/15)- The Food and Drug Administration, accepted the recommendation of its advisory committee, and thus for the first time in its history, has approved a biosimilar drug to be sold in the country. The biosimilar in question is Novartis AG Sandoz’ drug to be sold in the U.S. under the name of Zarxio, to compete with Amgen’s Neupogen. That drug was approved for sale in Europe in 2009, as Zarzio

Prior to the Affordable Care Act of 2010 there was no approval process set up to permit biologic or biosimilar generic drugs to be brought to market. As we noted in our item dated 1/10/15, an FDA advisory panel had recommended approval for Zarzio.

Biologic drugs are made with living cells, as opposed to typical drugs through the mixture of different chemicals. Amgen is appealing the decision, with a hearing to be held on March13 on its request for a preliminary injunction. Sandoz said it would not start selling Zarxio until a decision is rendered on the injunction, or April 10, whichever came first.

(1/10/15)- A Food and Drug Administration (FDA) advisory panel recommended approval of the first generic “biosimilar” drug in the U.S. The matter will now go before the FDA, which usually follows the recommendation of its advisory panels.

The drug in question is called EP2006, which Novartis AG’s Sandoz unit plans to market in the U.S under the name Zarxio. Amgen Inc. blockbuster drug  Neupogen presently has a lock on the market that is designed to increase white-blood-cell counts, and lower infection rates in patients undergoing chemotherapy.

As we noted in our item dated 1/31/13, the Affordable Care Act allowed biologic drugs to have a 12 year patent protection life.

(10/20/13)- Governor Jerry Brown of California, a Democrat, vetoed a bill that had been passed by both Democratic houses of the legislature (SB 598) that would have allowed generic biosimilar drugs to be substituted for a brand-name biologic only if the pharmacist notifies the doctor who wrote the prescription and the patient that the substitution was being made.

The Patient Protection and Affordable Care Act of 2010 allowed the Food and Drug Administration to approve copycat version of biologic drugs once they came off patent, which was not possible before this act was passed. These drugs are called biosimilars rather than generic biologics because they are not exact copies of biologic drugs.

Ordinary drugs are produced from chemicals, so that in mixing the exactly correct quantities of the chemicals, an exactly similar copy can be made. Biologic drugs are manufactured from live genes, so an exact copy can’t be made.

The California bill would have allowed biosimilars to be substituted if the FDA deemed the biosimilar “interchangeable” with the biologic drug. “Interchangeable” is a higher standard than merely being similar.

Opponents of the bill contended that once the FDA had declared a biosimilar interchangeable with the original, there was no need for the pharmacist to notify the prescribing doctor or the patient of the substitution.

The World Health Organization oversees the naming of drugs and the question now before them is if biosimilarsl should have different names than the biologic in question. The FDA is expected to decide that question for the U.S.

(3/8/13)- Because of the difficulty in replicating biosimilar drugs, several high-profile failures have been in the news lately.

Merck $ Co. backed off a plan to make its biosimilar version of Amgen Inc.'s version of its arthritis drug Enbrel, when that company gained a new patent for the old drug. Samsung Electronic's biosimilar unit suspended trials for a version of the cancer drug Rituxan and generic drug maker Teva Pharmaceutical Industries Ltd halted its own attempt at making its version of Rituxan.

In addition to the complexity of producing a biogenetic drug, the rules for producing these versions of the drug still have not been finalized under the Patient Protection Act which, for the first time called for the production of these type drugs upon the expiration of its patent.

Global sales of biologics, which were virtually nonexistent a decade ago, reached $157 billion in 2i011, according to a report from IMS Health, a market research firm.

Biotech drugs are produced by genetically modifying living cells that secrete proteins, and this process is quite complicated and difficult to control.

(1/31/13)- The battle to preserve the profitability of the biogenetic drug companies has now turned to the state legislatures.

The Patients Protection and Affordable Care Act of 2010 set up the terms for generic biologics. Biologic medications are made from living cells rather than by mixing chemicals to produce a drug.

Amgen and Genetech have proposed bills at the state level that would restrict a pharmacist from using a generic substitute for a "branded" biological medication.

At the federal level, the battle involves allowing a generic or biosimilar version of a brand name medication to use the same name as the biological medication.. Under most state rules, a pharmacist can substitute a generic version of a drug without consulting the physician who wrote the prescription. New proposals being put forward by the drug industry would require the pharmacist to consult the physician before allowing the substitution of a generic for a "brand" name drug

(6/30/12)- In upholding the constitutionality of the Affordable Patients Protection and Affordable Care Act of 2010, the provision in the act as to a 12-year patent life for biosimilar drugs was also upheld by the decision. For additional details on this matter please see our item dated 2/8/11 below.

As noted in our item dated 2/18/12, the Food and Drug Administration has issued the guidelines needed to be met to gain approval from the agency for a generic biosimilar drug.

(6/24/12)-The Biologics Price Competition and Innovation Act allows for the manufacturing and sale of generic versions of biotech drugs. It was embedded in the Patient Protection and Affordability Act of 2010, the constitutionality of which will be ruled on any day now by the U.S. Supreme Court.

The measure affords copyright protection to the original biotech drug patent holder for 12-years after approval. It also provides a regulatory roadmap for generic manufacturers of biosimilar drugs to go through without having to undergo a full clinical trial in order to gain FDA approval to sell its product.

Abbott Laboratories has filed a Citizens Petition with the FDA contending that the new law does not cover its biggest selling drug Humira. Abbott received its copyright before the law was passed.

Humira, a rheumatoid arthritis biotech drug that had $$3.4 billion in sales last year is projected to become the number 1-selling drug in the world this year. Abbott contends that before gaining approval from the FDA, it would have to reveal its trade secrets for the drugs and that this is therefore an invasion of its constitutional rights.

(2/18/12)- The Food and Drug Administration (FDA) finally came out with the guidelines to be met by companies hoping to receive approval for "biosimilar" drugs. The guidelines set out a series of steps that will be "an abbreviated pathway that will depend on existing data" on the patented biologic drug, said Rachel Sherman, FDA associate director for medical policy.

The U.S. is lagging the European Union, which already has more that a dozen biosimilar drugs on the market. Bernstein Research estimates that biologics with over $30 billion in sales will lose their patent protection by 2020. The new health care law allows for the adoption of biosimilar drugs after 12 years of patentability of a biotechnical drug.

Because of the expense in creating a biosimilar drug, it is expected that this version of a biotech drug will reduce the cost by only 10% to 20%, whereas when a "chemical" drug comes off patent, the generic drug companies usually brings down the cost ultimately by 90% to 95%.

(12/29/11)- Within the last three weeks, two of the leading biologic companies have announced alliances with generic drug companies in order to join forces in marketing biosimilar drugs that come off patent protection. As noted in our item dated 2/21/11, the new Patient Protection and Affordable Care Act limited patent protection for biological drugs to twelve years.

First came Biogen Idec's announcement that it would team up with Samsung to make and develop biosimilar drugs. More recently Amgen announced that it was teaming up with Watson Pharmaceuticals in a similar type of venture. In both these cases, the respective partnerships will not make generic versions of their own biological drugs.

Initially the biotechnology drug companies opposed any type of generic version of their drugs, since they claimed that since their drugs are made from living cells, unlike drugs made from chemical mixtures, the process could not be exactly replicated by generic versions of their medications.

Amgen and Watson will split the costs of development roughly in half, with Watson providing up to $400 million in cash or in-kind services. Watson would receive royalties and milestone payments on sales of the drugs.

Under the new law the Food and Drug Administration (FDA) is to develop rules for the approval of biosimilars. The agency has not released publicly any of its proposed new rules, so it will be quite a while before we see biosimilar generics for sale in the marketplace.

(2/21/11)- In President Barack Obama's proposed 2012 budget is a proposal to cut the patent exclusivity for biologics from 12 years down to 7 years. Thus, he would be revisiting the battlefield on this issue, since this was one of the planks in his 2008 presidential campaign.

The patent life for drugs is 20 years but the Patient Protection and Affordable Care Act of 2010 (PPACA) resulted in a 12 year patent protection period for biologic medications..

(2/8/11)- Although the Patient Protection and Affordable Care Act of 2010 (PPACA) provided for a 12 year patent protection for "biosimilar" drugs a controversy has arisen over the interpretation of the word "exclusivity" contained in the act.

The question is whether generic biotech companies have to wait the whole period of time before even beginning to seek approval, or can they start the process earlier, so that they are ready to market their product as soon as the 12 year period of time is up. The act was the vehicle under which biotech drugs first became patentable.

Senators John McCain (R.-Az) and Democratic Senators Sherrod Brown of Ohio, Tom Harkins of Iowa and Charles Schumer of New York sent a letter to the Food and Drug Administration siding with the generic drug companies on this issue. Earlier in January, 4 different senators sent a letter to the FDA siding with the patent holding biotech companies who claimed that "incentives for innovators to research and develop new treatments" dictate that the generic companies can not initiate the process until the patent expires.

A spokesman for Medicare said that the agency paid more than $2 billion for three anti-anemia biologics in 2009.

(11/10/10)- Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency are expected to set the rules, later this month, as what they will require before approving for sale "biosimilar" drugs. Under the provisions of the health care legislation that was passed this year, the makers of biological drugs are protected from generic competition for 12 years after they launch their product.

Unlike drugs that have a chemical makeup, biologics have proteins that can't be copied the way a chemical drug can be duplicated. Will that mean that a biologic generic will therefore have to undergo its own clinical trial before a regulatory body can approve it?

Once the rules have been set in all likelihood the matter than will have to go through the judicial process, before this matter finally gets resolved.

(7/29/10)- President Barack Obama's heath-care reform act that passed in 2010 allows the FDA to approve generic biologics to be marketed, with the FDA setting the rules as to what is required to gain approval.

The FDA recently approved the first generic version of the blood thinner Lovenox (enoxaparin) to be sold in this country. Lovenox, is manufactured and sold by Sanofi-Aventis SA, while the generic version thereof will be marketed by a subsidiary of Novartis AG.

Sanofi's subsidiary, Momenta indicated it may bring legal action to prevent the generic version of Lovenox to be marketed because the drug is too complex to be copied safely. Lovenox is drawn from animal proteins, and is in the middle of the categorization of a traditional chemical drug and a biologic drug which is made from human proteins.

(11/30/09)- Both versions of the proposed Senate health-care reform legislation and the House version of the legislation contain an approval process that allows generic versions of biologic drugs. In both houses the bills would prohibit generic-drug companies from competing with sales of brand-name versions of the biologics for at least 12 years.

Senator Sherrod Brown (Dem.-Ohio) said that he plans to fight to reduce the exclusivity period in the final bill, as well as "evergreening" provisos that may allow brand-name makers to extend the monopoly period by introducing slight changes to their product so as to gain extra exclusivity periods.

President Obama had proposed a 7-year period of exclusivity for biologics in his proposed budget back in February.

(11/3/09)- The proposed health-care bill that will be brought before the House shortly includes a provision creating a way for the Food and Drug Administration to approve generic versions of biologic drugs.

The proposed bill gives brand-name drug companies sales exclusivity for 12 years, and allows them to extend that time frame, with minor changes to their formulas.

(8/5/09)- You may ask why does a drug's market exclusivity period matter at all, since drugs are covered under patent protection for a period of 20 years. The problem arises because the FDA usually does not approve a drug for sale and usage until several years after the patent has been granted.

How big will the savings be, if generic copies can be made of patented biologic drugs. Biologic copies of generic drugs are called "biosimilar", not biologic generics because it is difficult, if not impossible to make an exact copy of a biologic drug. Remember that biologic drugs are made from live cells, and that means it is virtually impossible for a similar version thereof to be exactly the same.

Because even small changes might affect a drug's safety or interaction, biosimilar drugs would have to undergo their own expensive testing, and not be able to rely on the tests as is done on "small molecule pills". Since this can be a very costly process, it is estimated that a biosimilar drug could be sold at only about a 25% discount to the patented version of the drug.

In Europe, which has approved biosimilar versions of three biologic drugs, companies have priced these drugs at only a 20% to 30% lower price than the patented version of the drug.

The Congressional Budget Office has estimated that biosimilars might save the government only about $10 billion in the next 1 years. Biologics accounted for about $46 billion, or 16%, of total prescription drug sales last year, according to IMS Health, a market research firm. Also please keep in mind that pharmaceuticals accounted for only about 10 percent of the nation's overall health care spending last year, according to that same firm.

(7/25/09)- The Senate Health, Education, Labor and Pensions Committee voted to give biologics 12 years of market exclusivity. The White House had proposed 7 years. Representative Henry Waxman (Dem-CA), chairman of the House Energy and Commerce Committee favors only 5 years of market exclusivety.

Legislation expected soon from the Senate Finance Committee will leave out cost-cutting steps as part of an agreement with the industry and the White House, according to word that was leaked to the media.

Senator Edward Kennedy (Dem.-Mass.), who chairs the committee and also the state where many biologic companies reside introduced the 12-year proposal.

The biologic industry is growing at a rate of 18% a year and could hit $100 billion in sales by the year 2011. Other Democrats on the committee who strongly favor his proposal are Patty Murray (Dem-Wash.) and Barbara Mikulski (Dem-Md).

For more on this matter please see our item dated 4/2/09) below.

There are at least two items that are missing from the committee's proposal that also standout. The missing items include two planks of the Obama campaign platform: allowing cheaper drugs to be imported from Canada, and giving the federal government the right to negotiate Medicare drug prices with the drug companies on a centralized basis, instead of the present system wherein the Medicare Part D insurers individually negotiate drug costs with the drug makers.

(4/2/09)- Six senators have introduced legislation in the Senate, similar to Representative Henry Waxman's legislation in the House that we discuss in our item dated 3/16/09 below, that cuts the time allowed before generic versions of biotechnology drugs could compete with the originals to five years. Present law calls for a 12-year period of exclusivity for biologic drugs.

Senator Charles E. Schumer (Dem-NY) stated: "You have a new president, a new chairman on the House and most of all the need to cut costs to achieve national health care."

The bill would give the FDA the discretion to approve generic versions of biologic drugs with less extensive testing.

(3/16/09)- Representative Henry Waxman, the California Democrat who heads the House Energy and Commerce Committee has introduced a bill that would clear a regulatory path for generic drug manufacturers to produce generic versions of biologic drugs after a five year period of market exclusivity. He had introduced similar legislation twice before to no avail.

His bill is co-sponsored by Republican Nathan Deal of Georgia, who had previously opposed such legislation. Senator Charles Schumer, the New York Democratic Senator said that he would introduce similar legislation in the Senate shortly. Former Senator Hillary Clinton, who is the present Secretary of State was a leader while she was in the Senate in having this type of legislation enacted.

Unlike traditional drugs, which are manufactured by chemical interactions, biotechnical drugs are generally proteins manufactured in living cells. Makers of generic biologics must go through the same expensive and time-consuming clinical trials and other requirements that new drugs face. Regular generic drugs must only show bio-equivalency, and not have to undergo the expense of having a new clinical trial before getting the generic drug approved by the FDA for sale to the public.

The Waxman bill would set a five-year period of exclusivity, while the major biotech companies are hoping for 14 years of exclusivity. The Waxman bill does not state whether or not the generic drug makers would have to undergo clinical trials before gaining approval of their product from the FDA

A bill introduced in the House in 2007 from Rep. Joe Barton (R., Texas) and Rep. Anna Eshoo (D., Cal.) that was more favorable to brand-name biotech companies called for 12 years of exclusivity.

Please see:
Patents and Prescription Drugs-Part I
Patents and Prescription Drugs- Part II


By Allan Rubin
updated November 21, 2019

To e-mail: hrubin12@nyc.rr or

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