Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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The Biosimilar "Patent Dance" Being Challenged by Novartis in the Supreme Court

The Biosimilar "Patent Dance" Being Challenged by Novartis in the Supreme Court | Pharmaguy's Insights Into Drug Industry News |

A landmark lawsuit that could allow biosimilars to be launched in the US market more quickly is scheduled to be heard in the Supreme Court in April.


The suit has been brought by Novartis and will seek to overturn a US law that requires companies who secure approval for biosimilar drugs wait 180 days before they can commercialise the products. It is being supported by other biosimilar developers including Pfizer's Hospira subsidiary, Celltrion and Mylan.


Novartis is appealing an earlier ruling which ordered the company to delay launch of Zarxio, its version of Amgen's white blood cell stimulator Neupogen (filgrastim) and the first biosimilar to be approved in the US. Novartis won approval for Zarxio in March 2015 but was unable to launch until September of that year.


The Swiss pharma company has argued that the six-month delay constituted an unwarranted additional period of marketing exclusivity for branded biologic drugs that is unfair for biosimilar developers as well as healthcare payers and patients who have to wait longer for cheaper treatment options.


The legal wrangling centres on the interpretation of the Biologics Price Competition and Innovation Act (BPCIA), which created the regulatory approval pathway for biosimilars in the US.


Novartis' previous ruling did away with a requirement for biosimilar companies to inform branded product companies of their intentions to seek FDA approval 180 days in advance, which resulted in the so-called 'patent dance', with biosimilars tied up in the courts on patent infringement proceedings. The 180-day post-approval rule was however introduced at the same time.


"If not reversed, [the rule] will delay access by patients to all biosimilars for six months longer than Congress intended," said Novartis in a petition asking the Supreme Court to hear the case.


The Supreme Court will also hear an appeal by Amgen, which argues that brand name companies should be able to access a copy of the biosimilar marketing application dossier after approval. This was previously required but was overturned in the earlier Zarxio ruling.

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Biosimilar Drug Names Mean a Lot in Terms of Saving Money

Biosimilar Drug Names Mean a Lot in Terms of Saving Money | Pharmaguy's Insights Into Drug Industry News |
What's in a name? A lot, according to groups battling over whether biosimilar pharmaceutical products should be allowed to use the same nonproprietary name as branded products.

In March, in its first approval of a biosimilar product, the Food and Drug Administration designated the Sandoz product Zarxio with the placeholder nonproprietary name “filgrastim-sndz.” That was a compromise from labeling it simply as filgrastim, the nonproprietary name for the brand-name product, Neupogen, for which it is considered a biosimilar. 

Experts estimated that Zarxio could be sold at a discount of up to 35% of the price of Neupogen, a blockbuster cancer biologic produced by Amgen, which can cost about $3,000 for 10 injection treatments.

Some estimates have projected the biosimilars market in the U.S. will grow to $60 billion by 2020 as the patent protections on a number of biologic medications are set to expire over the next several years.

An Express Scripts report estimated that as much as $250 billion could be saved over the next decade if biosimilars being developed are approved for 11 biologic drugs that are slated to lose patent protection in the coming years.

“In the near term, the first-order obstacles (for the biosimilars industry) are the lack of interchangeability and the prevention of automatic substitution,” said Andy Pasternak, a partner and healthcare analyst at Bain & Co. in Chicago, a management consulting firm. “Once products overcome those, the naming issue becomes more significant.

Developers of biosimilar products such as Sandoz have been mired in legal battles for the past several years with manufacturers of branded biologic products that seek to block or delay the introduction of biosimilars. In addition to the lawsuits, biosimilars also face regulatory challenges that could slow their growth, Bain analyst Pasternak said. A key issue is interchangeability. 

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We are one step closer to a new generation of cheaper drugs

We are one step closer to a new generation of cheaper drugs | Pharmaguy's Insights Into Drug Industry News |
And Obamacare paved the way.

With the high cost of specialty drugs capturing so many headlines these days, here's a bit of a change of pace: A new wave of cheaper drugs marked a major milestone Thursday.

The Food and Drug and Administration for the first time has accepted an application for a copycat version of what's known as a biologic, which is a complex drug made from proteins of living organisms. These biologics are cutting-edge therapies that can be more effective than regular drugs made from chemicals — and, not surprisingly, they also can be expensive. For example, some biologics to combat rheumatoid arthritis, a disease affecting about 1 percent of the adult population, can cost more than $5,000 a week.

While cheaper generics now dominate the U.S. market for traditional drugs, accounting for about 85 percent of all prescriptions, you still can't get another version of biologic drugs in this country. That's about to change, though, because of a provision included in the Affordable Care Act that provides a pathway for copycat biologics, known as biosimilars, to enter the U.S. market.

The biosimilars' potential for savings in the United States seems to be pretty huge. The pharmacy benefits manager Express Scripts, which has actively advocated for more rapid adoption of biosimilars, estimates that the United States would save $250 billion in health-care spending over the next decade if just 11 biologics had biosimilar alternatives.

Thursday's FDA application from Sandoz is just the first step. The company, which already markets its biosimilar in 40 countries, could gain final FDA approval as early as the first quarter of 2015, according to the Avalare Health consulting firm. With so much concern from health-care payers over a projected rise in U.S. drug spending in the next few years, the development of domestic biosimilar market is something worth watching

Pharma Guy's insight:

Sandoz is the generics division of Novartis. Other pharma companies are fighting tooth and nail to keep biosimilars off the market in the U.S.:..

... such as Abbott's April 2, 2012 citizen's petition against FDA approval of biosimilars (read more about that and find a copy of the petition here: "Abbott Labs Petitions FDA to Disallow Biosimilars"). 

"If the challenge succeeds," says WSJ, "less-expensive versions of complex biologic drugs couldn't go on sale in the U.S. for years, and consumers may never have access to facsimiles of existing treatments such as Abbott's rheumatoid arthritis therapy Humira, which had $3.4 billion in U.S. sales last year and is projected to be the world's No. 1-selling drug this year."

NOTE: Humira topped the list of most advertised brands in 2013. See 

The Top 20 DTC Ad Spenders in 2013 Virtually Ignored Digital
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The Dog-Eat-Dog-Eat-Dog World of Biosimilars!

The Dog-Eat-Dog-Eat-Dog World of Biosimilars! | Pharmaguy's Insights Into Drug Industry News |

Amgen took one step closer to approval for its biosimilar of the world’s biggest-selling drug last night, but analysts don’t see it hitting the market this side of 2020 as a bitter patent battle continues.


The FDA advisory voted 26-0 that its version of AbbVie’s ($ABBV) Humira (adalimumab), currently known as ABP 501, should be approved along the same lines as the original drug--which includes licenses for rheumatoid arthritis and plaque psoriasis, as well as Crohn's disease and ulcerative colitis (UC).


Humira makes around $14 billion (with $8.4 billion made in the U.S.) a year and depending on how Amgen decides to price its copy (typically in Europe biosims are around 25% cheaper than the original), it could be set to eventually take a fair chunk of that away.


So, champagne corks popping at Amgen? Not quite, as even if, as expected, it gains full approval for all indications this year, it will likely not be launching its drug until 2022 if AbbVie has anything to do with it.


That’s because the two have locked horns in an increasingly bitter patent war, as AbbVie believes it has another 6 years of legal protection before anyone can release a biosimilar version. The dispute is still ongoing in the courts.


But in a reverse of fortune, Amgen is in fact today playing the role of AbbVie as the FDA panel turns its attentions to a biosimilar version of its blockbuster drug Enbrel (etanercept), which is indicated for rheumatoid arthritis and other chronic autoimmune conditions.


Novartis is seeking an approval for its Enbrel copy GP2015, which FDA staffers have already said in documents posted on the agency’s site this week is “highly similar” to its reference product, and the five licenses Enbrel has. The panel will meet today to discuss whether it too should recommend approval.


But guess what? In a familiar sounding scenario, Amgen is suing Novartis’ generic and biosimilar unit Sandoz on the grounds that its biosimilar infringes several of Enbrel's patents, so any launch could also be delayed.


And Amgen was in fact the first to succumb to biological copies in the U.S. when, just over a year ago, the FDA approved its first biosim in the form of Zarxio (filgrastim-sndz) from Sandoz--a biosimilar of Amgen's chemotherapy side effects drug Neupogen (filgrastim).


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Trade Agreement Helps Big Pharma Brands Block Generics & Biosimilars

Trade Agreement Helps Big Pharma Brands Block Generics & Biosimilars | Pharmaguy's Insights Into Drug Industry News |
US negotiators in Trans-Pacific Partnership (TPP) talks fought on behalf of big drug-making companies, championing intellectual property laws that would protect their profits from competition by generic medications, leaked documents have revealed.

Provisions in the draft text could make it extremely difficult for makers of generic drugs to compete with brand-name pharmaceuticals overseas, notes Politico. They would also block the sales inside the US of generic “biologics,” new and expensive treatments for dangerous maladies, thus restricting Americans’ treatment options.

Among the most controversial provisions in the draft document is the US insistence on “patent linkage,” which would bar governments of TPP member countries from approving generic drugs if there were any outstanding patent disputes. This would allow drug companies to quash competing generics simply by filing patent claims.

There’s very little distance between what Pharma wants and what the US is demanding,” Rohit Malpani, director of policy for Doctors Without Borders, told Politico.

Pharma Guy's insight:

DeLauro, Slaughter, Schakowsky Statements on Leaked Intellectual Property Chapter of Trans-Pacific Partnership


NEW HAVEN, CT—Congresswomen Rosa DeLauro (D-CT), Louise Slaughter (D-NY) and Jan Schakowsky (D-IL) released the following statements today on the leaked Intellectual Property chapter of the Trans-Pacific Partnership:


“The leaked intellectual property chapter continues to reveal the concerns that we and our colleagues have raised over the substance of the Trans-Pacific Partnership,” DeLauro and Slaughter said. “People who have access to this agreement recognize that this is a massive corporate give away to Big Pharma. We have seen from other leaked sources that industry lobbyists have been directly involved with writing portions of the trade agreement. Despite claims by the Administration that the text may change significantly, the Republican majority just voted to give away Congress’s only source of leverage to improve the agreement by granting the Administration fast track authority.


“We should not sacrifice public health and access to affordable medicine at home and abroad in order to promote the financial interests of the world’s largest pharmaceuticals,” they continued. “The text proves that the Administration has essentially worked as a lobbying arm of Big Pharma, working to extend some of the patents and cripple the generic drug industry with unnecessary regulation. We will continue to demand that this agreement be released from the shadows into the light of day so that the American people can see what is being negotiated on their behalf, against their interest. We must defeat the TPP.”


Schakowsky said: “This leaked information confirms what we’d all feared: as currently drafted, the United States is pushing on TPP nations, over their objections, to agree to a provision that would benefit multinational corporations and big Pharma at the expense of health care consumers here in the United States and around the world.


“Rather than promoting the objections of big Pharma, we should be working to lower drug prices. We should not be crafting trade policies that raise the cost of life saving medications by them by blocking competition from generic drugs. Enough is enough – our negotiation position leads to responsible trade policies that put lives ahead of corporate profits.”

CAROL ISELIN's curator insight, December 5, 2015 3:06 PM

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