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In 2004, the European Commission adopted a new directive that paved the way for legal approval of biosimilars in the European Union (EU). To date, five (5) biosimilars have garnered marketing approval in the EU. Of the five, two are generic versions of recombinant growth hormone (rHGH)–Omnitrope (Sandoz) and Valtropin (Biopartners). The remaining three are “knock off” versions of erythropoietin alpha–Binocrit (Sandoz), Epoetin alpha Hexal (Hexal) and Abseamed (Medice Arneimittel Putter).

There is no doubt, at this point, that Europe is leading the way in the biosimilar space. However, it is important to point out that a variety of biosimilars, developed by Indian generic manufacturers and others, are already being sold in less- regulated Asian markets (see Table 1). Unfortunately, political issues and the fierce struggle between innovator

Table 1. Biosimilar Manufacturers and Their Products

biotechnology companies and generic manufacturers have delayed development of legislation for regulatory approval of follow-on biologics (American lingo for biosimilars) in the US. Further, and perhaps more perplexing, the FDA has been reluctant to issue any guidance on the topic. However, rising drug costs and increasing expenditures on biologics (both by Medicare and private insurers) have left American lawmakers with no choice but to craft legislation for approval of follow-on biologics.

In the first half of 2007 alone, three different bills were proposed to craft a statutory pathway for the approval of follow-on biologics under the Biologic License Application (BLA). The first of these bills–The Access to Life-Saving Medicine Act– was introduced into Congress by Representative Henry Waxman (CA) and into Senate by Senator Chuck Schumer (NY) in February. The second bill–the Patent Protection and Innovative Biologic Medicine Act –was introduced in Congress in April by Representative Jay Inslee (WA). Neither bill made any progress. This is because the Access to Life-Saving Medicine Act was considered to be heavily pro-follow-on whereas the Patent Protection and Innovative Biologic Medicine Act was deemed to favor innovator companies and did not provide any financial incentives for follow-on manufacturers.

A compromise was reached by both Republican and Democrat Senators and the Biologics Price Protection and Innovation Act was approved by the Senate on June 27.  It proposes 12 years of market exclusivity for the patent holders but also one year of exclusivity to the first follow-on biologic to be approved as interchangeable with the reference product.  I previously aired my views on the proposed legislation. For a more in depth analysis of the issues and the bills, please read this.

Recently, there was an important new regulatory development in the European biosimilar landscape. Sandoz’s EPO, Binocrit, received the same nonproprietary name (INN) as Amgen’s original erythropoietin alpha (Epogen in the US, Eprex in Europe).This was a big win for the biosimilar industry because the INN debate had been raging in the EU for the past several years. Innovator companies wanted biosimilars to have different INN than their products whereas biosimilar manufacturers were lobbying for identical INN designation. An identical INN designation allows for  interchangeability of medicines. The fact that EMEA granted Binocrit the same INN number as Eprex, means that the agency views the two products as biologically-equivalent and interchangeable. This paves the way for EU pharmacists to freely substitute Binocrit for the more expensive Eprex. Also, it sends a message to US lawmakers and FDA that the EU considers certain biosimilars as interchangeable with their innovator counterparts. As you may have guessed, the issue of interchangeability is being hotly debated and contested by advocates on both sides of the follow-on biologics fence.

The US is clearly dragging its feet in the follow-on biologics arena. The prime driver of this inertia is the imagined loss of revenue that many innovator companies fear will occur if the US ultimately divines a regulatory approval pathway for follow-on biologics. That said, with Europe and India leading the charge into Asia, it looks as though the US is going to loss a substantial amount of money (not to mention market share) anyway.

With regard to biosimilars in the US, it is no longer a question of “if” but “when.” That said, I think that the one seminal issue that needs to be addressed is what to call these things in the US?  In my opinion, the European moniker, biosimilar, is particularly apt and appropriate for this new class of medicines. Unfortunately, we Americans don’t like to play second fiddle to anybody, especially the Europeans. With this in mind, I have no doubt that they WILL NOT be called biosimilars in the US. Whatever they are called, don’t be surprised to find them your pharmacist’s shelves in the next couple f years!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!

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According to Johnson & Johnson, a panel of advisors for the Food and Drug Administration, in a surprise decision, supported keeping Epogen, Procrit and Aranesp from Amgen and Johnson & Johnson on the market for use in cancer patients who are anemic from chemotherapy.

The advisor panel voted 13-1 to keep Amgen's Aranesp and J&J's on the market for use with chemotherapy. The recommendation was very surprising because over the last year FDA has scrutinized the drugs because of safety concerns and recently added new warnings to the labels. Many analysts expected further recommendations for restrictions. Although the advisory panel vote is non-binding, FDA usually follows the advice of its panels when making regulatory decisions. However, it is important to note that FDA has not followed the advice of several advisory panels in the recent past.

The positive advisory panel vote is good news for J& J and Amgen because billions of dollars in revenue are at risk for the cancer indication.  I bet that J & J and Amgen executives breathed a collective sigh of relief after hearing the news!  Maybe that loud noise I heard earlier today was the popping of champagne corks at J & J corporate headquarters in New Brunswick, NJ.  

To quote Mark Twain: “The rumors of my death have been greatly exaggerated” is particularly apt for Amgen and J &J after today’s decision.

Until next time….

Good Luck and Good Job Hunting!!!!!!

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Erythropoietin (EPO) is a hormone (protein) that regulates red blood cell production in humans. Back in the 1980s, scientists at a fledgling biotechnology company called Amgen determined that recombinant EPO was highly effective for treating anemia. Amgen owned the intellectual property rights to the EPO gene and decided to sell the recombinant protein encoded by EPO (called epoetin) as a treatment for anemia.EPO is known to alleviate fatigue caused by anemia by stimulating red blood cell production.

Amgen’s first EPO product, called Epogen, was approved in 1989 to treat patients suffering from anemia associated with renal failure. Procrit, Johnson and Johnson’s version of EPO (which was licensed from Amgen) was approved four years later in 1993 to treat chemotherapy-induced anemia. Aranesp, a longer acting version of EPO which is also manufactured by Amgen was approved in 2001 for anemia associated with chronic renal failure and in 2002 for chemotherapy-induced anemia in cancer patients.  All of the EPO drugs have gained blockbuster status and, over the past five years or so, the annual revenue generated by these drug is estimated to be $6.0 to $12 .0 billion.

Since their approvals, EPO, Aranesp and Procrit have been administered to tens of millions of kidney dialysis and cancer patients undergoing chemotherapy with minimal safety concerns and generally positive outcomes. However, with the looming specter of generic biologics (EPO lost patent protection in 2004) and competition from companies like Roche developing competing EPO products, Amgen stepped up its efforts to promote and sell EPO and Aranesp. This, in turn, caused EPO drugs to be used by many physicians, which ultimately resulted in additional safety warnings and a label change for all EPO products. The label change coupled with unrelenting negative publicity about Amgen’s promotion of its EPO franchise, caused its stock price to plummet and forced the company late last year to lay off 14% of its workforce.

Like other biotechnology and pharmaceutical companies, Amgen sought to find ne indications for its EPO products. To that end, there was some compelling evidence several years ago which suggested that EPOmight increase survival of cancer patients, when used with radiation and chemotherapy. The idea was that higher oxygen levels in the blood would make the radiation or chemotherapy being used to treat the patients' cancer more effective. With this in mind, several groups of investigators initiated human clinical trials to determine whether EPO treatment would benefit non-anemic cancer patients. Unfortunately, the New York Times reports that results from no fewer than eight clinical trials suggest that EPO drugs might actually promote rather than slow tumor growth and hasten the death of cancer patients.

Amgen believes that the increased trial deaths among EPO-treated patients resulted from blood clots rather than by promoting tumor progression or growth. The company contends that the amounts of EPO used in the trials exceeded what is recommended in the drug label and, at those levels, blood clots are a known common side effect. On the other hand, there is a growing body of evidence from a variety of sources which suggests that some types of human tumors express EPO receptors, which when stimulated by EPO binding, induces tumor cell proliferation. To make matters worse, when Procrit was first approved to treat chemotherapy-induced anemia, FDA regulators suggested in briefing documents that there may be a “hypothetical risk” that EPO could stimulate tumor cell growth. Nevertheless, neither FDA nor most EPO experts believe at this time that a direct link between EPO use and tumor growth has been established. Everyone agrees that more research must be conducted to verify or refute this idea.

Tomorrow, an advisory committee to FDA will consider placing further safety restrictions on the use of EPO drugs.  If they feel that blood clots were responsible for increased death among EPO-treated cancer patients then the recommendation would be relatively simple–only use the recommended modest levels of EPO to treat cancer patients as indicated on the product label.  However, if they believe that EPO directly stimulates tumor growth then even the currently recommended modest doses of the drug may be too risky to treat cancer patients. Regardless of the outcome of the tomorrow’s FDA advisory meeting, it is clear that Amgen’s flagship EPO franchise may be in serious jeopardy.

Until next time….

Good Luck and Good Job Hunting!!!!!!!

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As the debate continues to rage in the US about how to regulate biogeneric drugs, the European Medicines Agency (EMEA) has given the go-ahead to Hospira and Stada to sell their copycat version of Johnson & Johnson's anemia drug Procrit.

The European Commission approved Retacrit (epoetin zeta), a biosimilar version of erythropoietin (EPO), to treat anemia associated with chronic renal failure and chemotherapy. EMEA regulators determined that the drug was comparable in efficacy and safety to Procrit.

The EPO market is a large one and more than 250,000 patients in Europe are estimated to be treated with epoetin alfa, which is marketed under various brand names, Procrit (JNJ; US), Eprex (JNJ; Europe) and Epogen (Amgen; US). Worldwide annual sales of EPO drugs are estimated at more than $7 billion, $600 million of which comes from Europe.

The approval for Retacrit comes some three months after Novartis’ generics unit Sandoz got the first go-ahead in Europe to develop its version of epoetin alfa. Sales of Retracrit will begin in Germany in early 2008.

When are American pharmaceutical and biotechnology executives going to wake up and realize that they will lose millions in revenue to biosimilar competition?  I think the old adage; “If you can’t beat ‘em, join ‘em” is apt when talking about the biogenerics industry.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

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Swiss pharmaceuticals producer Roche Holding AG said Thursday it has received approval from the U.S. health authorities for its anemia drug Mircera, but is still awaiting resolution of a patent case before launching the drug in the United States.

Mircera, which has been approved by the U.S. Food and Drug Administration for patients with anemia caused by kidney failure, is the subject of a legal tussle between Roche and rival Amgen Inc.

The new EPO-like drug is already sold in Austria, Sweden, Germany, Britain and Norway, Roche said.

Amgen will fight Roche to the end on this one. But, I think Roche will prevail. Let’s hope so!!!!!!!

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The New York Times reported today that an FDA advisory committee voted on Monday against imposing a new restriction on the use of EPO-like drugs to treat dialysis patients with kidney disease, offering a rare reprieve to Amgen, the manufacturer of the drugs.

The panel voted 14-to-5 against an F.D.A. proposal to set a fairly specific upper range on the drugs’ use. Several studies have linked overuse of the drugs to cardiovascular problems and deaths and, when used to treat cancer patients, to a worsening of tumors.

Nevertheless, although yesterday’s vote made it less likely that there would be drastic restrictions on the use of the drugs in kidney patients, the levels of use are unlikely to return to those common before the safety concerns took hold. Even while rejecting the proposed ceiling, most panel members recommended a treatment target lower than what some dialysis clinics and kidney specialists previously used.

Further, the F.D.A. said it was proposing to remove assertions on drug labels that assert that use of these drugs improved the quality of life for patients, saying the data to support such claims was inadequate. In March, the F.D.A. changed the labels for EPO to say that these drugs should be used as sparingly as necessary to avoid blood transfusions and that hemoglobin levels should not exceed 12 grams a deciliter.

Yesterday’s panel was far easier on Amgen than one in May that considered the safety of the drugs for use by cancer patients. After that meeting, Medicare sharply reduced its reimbursement for EPO drugs used in cancer treatment. This decision caused Amgen’s stock price to plummet to its lowest levels in almost a decade.

Despite this small victory, it is unlikely that the decision will affect the previously announced layoffs scheduled to take place in the very near future at Amgen.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

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I posted a piece several months ago that predicted that Amgen may be in for a rocky ride as a result of slowing revenue growth (due to increased regulatory scrutiny of its EPO franchise) and a relatively weak drug development pipeline. Not surprisingly, the Wall Street Journal reported on Thursday that there are signs that employee layoffs are likely in the near future (I am sure that this is a not a surprise for current Amgen employees). In documents filed with the SEC on Thursday, corporate language appeared that included phrases like “improve our cost structure,” “seek greater efficiencies” — corporate speak that layoffs are imminent.

Industry experts estimate that layoffs of up to 15% of Amgen’s workforce may take place. In support of this, last week, CEO Kevin Sharer sent a message to employees through the company’s voicemail system, saying changes could be in the offing.

I think it is time for Amgen employees to remove the dust from their resumes!!!!!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!

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