Posts Tagged “Mylan”

Lawmakers accuse drugmakers Mylan, Teva of ‘coordinated obstruction’

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Lawmakers accuse drugmakers Mylan, Teva of ‘coordinated obstruction’

U.S. lawmakers on Wednesday accused three major pharmaceutical companies of “coordinated obstruction” and “apparent efforts to stonewall” an investigation on generic drug prices launched in 2014. Chairman of the House Committee on Oversight, Elijah Cummings, D-Md., along with Sen. Bernie Sanders, I-Vt., sent letters to Mylan, Teva Pharmaceutical and Heritage Pharmaceuticals asking them to turn over documents, according to a joint statement Wednesday. The lawmakers said they decided to open an investigation following findings in a lawsuit filed by 44 states in May that accused the drugmakers and others of inflating drug prices and stifling competition for generic drug versions.

“Not only did your company’s apparent obstruction undermine our investigation, but it may have caused further harm to patients and health care providers by delaying the discovery of evidence about the companies’ price-fixing,” Cummings and Sanders wrote in each of the letters, dated August 13. Shares of Mylan and Teva Pharmaceutical were each down roughly 8% on Wednesday. A spokesperson for Mylan said the company, with the help of outside counsel, is investigation the allegations made in the states’ lawsuit.

“We have not found any evidence to corroborate the allegations. We are prepared to make our case in a court…

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Will big pharma exit the biosimilar market when margins start dropping?

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Will big pharma exit the biosimilar market when margins start dropping?

As prices drop, Big Pharma will exit the biosimilar space over the next five to 10 years, says industry expert Sarfaraz Niazi. Amgen, Novartis and Pfizer refute the claim, saying they are in the sector for the long-term.

Blockbuster biologic originator companies are, by definition, Big Pharma firms and the target of biosimilar developers. Roche and AbbVie, two of the firms most susceptible to biosimilar erosion, have vocalized the need for a stringent regulatory framework – including calls for appropriate data, individualized labels, and unique identification for all biotherapeutics – while attempting to bat off competition by reformulating products and beefing up both their pipelines and IP.

But at the other end of the Big Pharma spectrum, there are several firms that dominate the biosimilar European and US markets, namely Novartis, Pfizer and Amgen, which all claim to have some of the largest biosimilar pipelines in the industry.

Novartis – through its Sandoz division – has been marketing biosimilars for over a decade in Europe, and was the first to launch a biosimilar in the US after Zarxio, its version of Neupogen (filgrastim), received approval in 2015.

Pfizer, which was the first to launch a version of J&J’s Remicade (infliximab)…

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FDA again approves record-breaking number of generic drugs

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FDA again approves record-breaking number of generic drugs

The Food and Drug Administration approved or tentatively approved a record-setting 971 generic drugs in fiscal year 2018 that ended last month, the agency announced on Thursday.

The total figure is slightly above the 937 final and tentative approvals in fiscal 2017, which itself was also a record. Generics are copies of brand name drugs and typically much cheaper. The Trump administration has pinpointed quickening generic drug approvals as a key way to bring down prescription drug costs.

“We’ll continue taking additional steps to help ensure patients have access to the drugs they need by making generic drug approval more efficient and predictable,” said FDA Commissioner Scott Gottlieb in a statement.

The FDA noted the high number of complex generic drugs that were approved in fiscal 2018, saying that 12 percent of the approvals were for complex products.

“We also will continue our focus on helping to bring more generic versions of complex drugs, like EpiPen, to the market,” Gottlieb said, referring to the allergy drug EpiPen of which drugmaker Mylan spiked the price in recent years. “In too many cases, there is no generic competition for these costly branded drugs even after they have lost their exclusivity protections.”

The…

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Mylan’s first FDA-approved biosimilar drug to become available soon

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Mylan’s first FDA-approved biosimilar drug to become available soon

Mylan’s first FDA-approved biosimilar drug should be available in a matter of weeks, a company official said.

Mylan, which has a 3,000-employee operation in Morgantown, along with Biocon, received the approval for Fulphila, biosimilar to the drug Neulasta, which targets infections suffered by some breast cancer patients as they are undergoing chemotherapy.

Mylan Head of Global Policy Marcie McClintic Coates told MetroNews the approval of the drug was a milestone for the company.

“Mylan has invested more than $1 billion in our biosimilar platform. We have more coming,” McClintic Coates said.

Biologic drugs, like Neulasta, are expensive and Mylan believes its product, Fulphila, will provide a much needed option.

“Being able to come out with alternatives to those in the same way that we have been able to help with many other drugs, traditional tablets and capsules and so forth. To bring generics is something really important to expand the number of people that have access to these medicines,” McClintic Coates said.

Mylan and Biocon haven’t yet set a price for Fulphila.

McClintic Coates, a White Sulphur Springs native, did interviews with several media outlets in the Mountain State last week, not only about the new drug, but also about…

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Big pharma CEO: Congress is not solution oriented

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Big pharma CEO: Congress is not solution oriented

Mylan CEO Heather Bresch hates having to answer to Wall Street.

“You can’t build a company in a quarter,” Bresch said in a new episode of CNN’s podcast “Boss Files with Poppy Harlow.”

“We have got to find better ways to measure ourselves and measure success,” Bresch said.

Bresch, who stepped into the chief executive role in 2012, has held firm in her decisions as head of the company — even when they’ve sparked national controversies.

She describes the pharmaceutical firm as a “stakeholder company,” rather than a shareholder company. The approach “allows us to take a lot of other things into consideration,” she said, aside from increasing sales from quarter to quarter. It’s also, on occasion, raised the ire of Mylan investors.

Shareholders were mad when Bresch blocked a takeover attempt by the Israeli drugmaker Teva in 2015. Teva offered to buy the shares at high premium, so the acquisition would have been lucrative for Mylan’s investors. Still, Bresch stands by her decision.

“We do believe in the long term,” she said. “I’ve said a well-run company delivers great shareholder returns, and we have. And we plan to continue to do so.”

Bresch’s efforts to create those returns have…

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EU proposes IP changes to ease export of generic drugs

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EU proposes IP changes to ease export of generic drugs

The European Commission has proposed changing intellectual property rules to allow generic and biosimilar drug manufacturers to sell their products in markets outside the EU before the patents expire in Europe. Doing so, the Commission says, will create jobs and growth in the European Union.

The news has sparked strong opposition from pharmaceutical companies, however, which say the change would disincentivise investment in research and development.

The proposed changes target Supplementary Protection Certificates (SPCs), which extend patent protections for drugs that require extensive testing before gaining regulatory approval. This prevents European generic and biosimilar drug makers from producing these drugs within the EU for a period of up to five additional years.

If introduced, the “export manufacturing waiver” would allow manufacturers of generics and biosimilars to begin making the drugs for export to markets outside of the EU before the SPC protection period has ended. The changes would therefore allow companies to launch generic and biosimilar versions in Europe more quickly once the SPC protections end, reports Science Business.

The proposal “could generate €1 billion net additional sales per year and up to 25,000 new jobs over 10 years,” EU industry commissioner Elżbieta Bieńkowska said in a statement on Monday.

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Why We May Lose Generic Drugs

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Why We May Lose Generic Drugs

The mood at the annual generic drug industry confab in Orlando in February was especially somber. The discussion during one panel was all about plunging drug prices, consolidation among drug-buying groups, and the increasingly cutthroat nature of the business. A top executive at Israel-based Teva Pharmaceutical Industries Ltd., the No. 1 supplier of generics in the U.S., which is laying off 14,000 employees and shuttering about half its 80 manufacturing plants, tried to lighten the mood with gallows humor: “Teva certainly has no challenges,” said Brendan O’Grady, the executive vice president who heads its North American commercial business. The joke hit the mark, perhaps because it landed so close to home.

The generic drug industry, which supplies almost 9 of 10 drugs prescribed in the U.S., is in crisis. These companies aren’t the superstars making cutting-edge cancer and hepatitis treatments that are priced through the roof. They’re the producers of bread-and-butter pills consumers often take for granted: antibiotics, arthritis treatments, medicines for diabetes and high blood pressure. With the profitability of these prosaic pills fading fast, companies are exiting important parts of the business. “We’re one of the companies that continues to make antibiotics, and we’ve asked ourselves for years why…

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When the new ‘pharma bros’ show up, prescription drug prices…

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When the new ‘pharma bros’ show up, prescription drug prices…

For at least the past three years, Todd Smith and Benjamin Bove have crisscrossed the U.S., offering a sure-fire fix for struggling pharmaceutical companies. And wherever they go, the price of prescription drugs tends to skyrocket.

While Martin Shkreli, nicknamed Pharma Bro, became notorious for sharply – and unapologetically – increasing drug prices, Smith and Bove have quietly plied their trade helping to kick-start drug company sales.

The Chicago-based duo has played important roles at no fewer than four companies that have raised prices on life-saving and other drugs by as much as 4,116 percent.

Their strategy is simple and, they say, good for patients: Thwart efforts by health plans to block access to drugs – and serve up what Smith calls their “special sauce” to get those meds into the hands of customers who need them.

The main ingredients include copays that are often zero, even for pricey drugs. Smith, 48, and Bove, 40, also offer the use of so-called specialty pharmacies – one of which they previously owned – to make it hassle-free for doctors and more affordable for patients. Yet critics point out that, over time, everyone might end up paying the price in the form of…

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Patient advocacy groups take in millions from drugmakers. Is there a payback?

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Patient advocacy groups take in millions from drugmakers. Is there a payback?

Pharmaceutical companies gave at least $116 million to patient advocacy groups in a single year, reveals a new database logging 12,000 donations from large publicly traded drugmakers to such organizations.

Even as these patient groups grow in number and political influence, their funding and their relationships to drugmakers are little understood. Unlike payments to doctors and lobbying expenses, companies do not have to report payments to the groups.

The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups tallied for 2015 — the most recent full year in which documents required by the Internal Revenue Service were available — dwarfed the total amount the companies spent on federal lobbying. The 14 companies that contributed $116 million to patient advocacy groups reported only about $63 million in lobbying activities that same year.

Though their primary missions are to focus attention on the needs of patients with a particular disease — such as arthritis, heart disease or various cancers — some groups effectively supplement the work lobbyists perform, providing patients to testify on Capitol Hill and organizing letter-writing and social media campaigns that are beneficial to pharmaceutical companies.

Six drugmakers, the data show, contributed a million dollars or more…

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Big Pharma, Insurance Giants in Heated Battle Over Drug Coupons

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Big Pharma, Insurance Giants in Heated Battle Over Drug Coupons

Drugmakers have launched a series of ads in their fight with insurance companies over copay coupons designed to save consumers money at the pharmacy checkout.

Big Pharma and Big Insurance are at it again. This time they’re fighting over copay coupons.

These coupons are provided by pharmaceutical companies to reduce consumers’ costs for brand-name drug purchases.

Some insurers have recently put restrictions on these coupons.

So, the pharmaceutical industry has struck back with a series of ads with slogans like “Why are middlemen trying to keep you from reaching your deductible?” and “You shouldn’t have to fight for your medicine.”

On the surface, copay coupons appear to be good things. They save you money, right?

But what you save at the pharmacy checkout may come back to haunt you later as higher insurance premiums.

To help you understand what’s going on, here’s a breakdown of the two sides of this heavyweight fight.

The copay coupon conflict

Copay coupons cover part of consumers’ out-of-pocket costs for brand-name medications. This money comes from the drugmakers.

So instead of paying $65 a month for a brand-name drug, you might pay only $4 a month with a coupon.

Drugmakers promote coupons as a way…

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