FDA to share full inspection reports with EU; Difficult week for Teva, J&J, Mylan

This week, Phispers brings you the latest from the world of biosimilars, with Samsung Bioepis tying up with Japan’s Takeda, Biocon transferring its biosimilar business to a subsidiary, and South Korea’s Celltrion denying reports that its proposed biosimilar of Herceptin could face delays in Europe. Teva faced yet another bad week, with two Congressmen in the US attacking it over price increases of its multiple sclerosis drug. Meanwhile, Mylan and J&J will have to pay millions of dollars for cases against them. In vaccines, GSK faces flak for shortage of its Hepatitis B vaccine in the UK. And Pfizer won a pneumonia vaccine patent battle in India.

Biocon transfers biosimilar business to subsidiary; Samsung Bioepis ties up with Takeda

A lot has been going on in the world of biosimilars. Last week, in a stock exchange filing, Biocon said it has withdrawn the dossier for the biosimilar products — Fulphila® (pegfilgrastim) and Ogivri® (trastuzumab). Since the approval of its trastuzumab and pegfilgrastim applications would require re-inspection of its drug product facility (for these products), the “request of withdrawal of the dossiers and re-submission is part of the EMA procedural requirements linked to this reinspection…,” Biocon said in the statement.

The announcement came a fortnight before the FDA was supposed to take a decision on the trastuzumab application.

This week, the board of Biocon approved the transfer of the biosimilar business of the company to Biocon Biologics India, a step-down subsidiary of the company, subject to the consent of its shareholders. The transfer of the biosimilar business has been done by way of a ‘slump sale’ as a going concern — wherein a sale is done for a lump sum consideration without values being assigned to the individual assets and liabilities.

Concerns also emerged over Biocon’s Herceptin biosimilar competitor — Celltrion — as it denied a news report that its proposed biosimilar of Herceptin (a breast cancer drug) could face delayed European approval due to late submission of data. With global sales of around US$ 7 billion a year, Herceptin is one of Roche’s best-selling drugs.

According to the Celltrion, the European Medicines Agency (EMA) found no lapses during a pre-approval inspection of its product site and drug substance Herzuma — its copy version of Roche’s Herceptin. The South Korea-headquartered biopharmaceutical firm also managed to hand in the documents that it was required to provide after inspection.

“We don’t expect any major changes in approval procedures although the inspection date had been pushed back a little because of differing schedules,” a Celltrion official said. There was news that the EMA could postpone approval of Herzuma to 2018 as the company failed to submit documents on time. However, it seems like Celltrion’s Herzuma may get EMA’s nod this autumn.

Any delays in approval procedures for Herceptin biosimilar candidates could have an impact on other drug makers eyeing the US$ 2 billion EU market for the original drug including another South Korean biosimilar firm — Samsung Bioepis — which filed for EU approval in September 2016.

The biosimilar industry is keeping a close watch on which of the two South Korean firms is the first to get the nod for its Herceptin biosimilar, after Biocon withdrew its application last week.

Meanwhile, Samsung Bioepis unveiled a new alliance this week — with Japan’s Takeda. Together with Takeda, Samsung Bioepis hopes to accelerate the development of effective therapies. The Japanese firm has been open to devising new alliances that will share the risk in order to broaden its overall drug development work.

More bad news for Teva as US Congressmen attack pricing of its flagship therapy

Two US Congressmen accused Teva of hiking the price of its flagship multiple sclerosis (MS) drug — Copaxone (glatiramer acetate) — by more than 1,000 percent since 1996. Copaxone generated US$ 4.22 billion in sales last year.

The Congressmen — Elijah Cummings and Peter Welch — want to fully investigate Teva’s pricing practices, while also calling out firms such as Novartis, Bayer and Biogen.

According to the Congressmen, a year’s worth of 20 mg Copaxone was priced at US$ 8,292 in 1996. This increased to US$ 51,315 in 2012 and US$ 91,401 in 2017. Lack of generic competition permitted Teva to increase the price of the drug to such high levels.

Cummings and Welch said they were launching an investigation into why prices for MS treatments have nearly quintupled since 2004. According to the National Multiple Sclerosis Society, the average annual cost of MS therapy rose to US$ 78,000 in 2016 from US$ 16,000 in 2004.

Meanwhile, Teva is planning to tie up with other drugmakers to fund some of its development pipeline as it struggles with debts and expiring patents. Teva needs funds to develop new drugs, and striking alliances with big pharma players is one way of doing that.

Earlier this month, Teva reported a steep drop in second-quarter earnings. Teva is saddled with debts of around US$ 35 billion, which it took on when it acquired Actavis (Allergan’s generic business) for US$ 40.5 billion last year.

Sanofi gains millions via Mylan’s EpiPen settlement; J&J to pay US$ 417 million in baby powder case

Last week, Mylan NV and the US Justice Department finalized a US$ 465 million settlement to resolve claims that Mylan had defrauded taxpayers and overcharged the government by misclassifying its EpiPen emergency allergy treatment as a generic drug.

EpiPen had become the center of a drug price-hikes controversy last year.

The probe into the price of EpiPen followed a whistleblower lawsuit filed under the False Claims Act that rival drugmaker Sanofi SA filed in 2016. As a result of the settlement, Sanofi will receive US$ 38.7 million as a reward, authorities said.

Meanwhile, lawmakers in the US say the settlement wasn’t tough enough. According to Democratic Senator Richard Blumenthal of Connecticut, the agreement was a “feeble fraction” of the US$ 1.27 billion that a government report found taxpayers may have overpaid for EpiPen over the last decade.

Mylan had acquired EpiPen in 2007. It is a handheld device that treats life-threatening allergic reactions by automatically injecting a dose of epinephrine. Mylan had raised the price of a pair of EpiPens to US$ 600, from US$ 100 in 2008.

J&J baby powder case: A US court directed Johnson & Johnson to pay US$ 417 million to a woman who alleged that the company’s baby powder causes ovarian cancer.

In her lawsuit, 63-year-old Eva Echeverria had claimed that she used the talcum powder from the 1950s till 2016, and developed ovarian cancer in 2007. Echeverria alleged that J&J failed to warn consumers about the risks involved in using their talcum powder. The court awarded the woman US$ 68 million as compensatory damages, and US$ 340 million as punitive damages.

Hikma raises price of diarrhea drug by 400 percent; Trump signs user fee law

Last week, the US saw another price-gouging incident. The US subsidiary of Hikma Pharmaceuticals Plc raised the price of a common diarrhea drug by more than 400 percent. Known as West-Ward Pharmaceuticals, the US division of Hikma is also charging more for five other medicines.

According to a Financial Times report, the average wholesale price of a 60 ml bottle of liquid atropine-diphenoxylate, a common diarrhea drug also known as Lomotil, went from about US$ 16 a bottle to US$ 84.

FDA Reauthorization Act: Last week, President Donald Trump signed the FDA Reauthorization Act of 2017 into law. With this, the FDA saw the end of a two-year long process that was threatening to disrupt its operations.

The law comes at a time when the FDA, under the new commissioner Scott Gottlieb, is approving generics at a record pace.

Though the legislation had been passed by both the houses of the Congress, it faced a number of threats, including Trump’s intent to fund the FDA entirely with user fees from companies. Between 2018 and 2022, the FDA is expected to collect US$ 9 billion in fees — US$ 8 billion for prescription drugs and US$ 1 billion for devices — based on the fee level set in the Senate bill.

GSK faces flak for Hep B vaccine shortage in UK; Pfizer wins vaccine patent in India

In the UK, drug giant GlaxoSmithKline faced flak and an increasing number of questions over shortages of its vaccine for the deadly liver disease hepatitis B. The shortage of this vaccine in the UK has led to rationing.

Earlier this month, Public Health England (PHE) took the rare step of advising doctors to limit prescription of the vaccine, citing a “global shortage”.

This comes at a time when GSK’s supplies of the vaccine to the US appear to be unaffected. The disparity has led to suggestions from liver disease campaigners that GSK may be “prioritizing” the massive American market.

Hepatitis B is considered a “silent killer” leading to 900,000 global deaths a year. However, the disease is more prevalent in the developing world and is rare in the UK. Meanwhile, the World Health Organisation (WHO), has said there is no global shortage of the vaccine. The WHO is responsible for monitoring stocks of vaccines worldwide.

In India, Pfizer Inc was granted a patent for its powerful pneumonia vaccine —Prevenar 13.

The decision bars other companies from making cheaper copies of the vaccine and allows Pfizer to exclusively sell it in India until 2026.

The patent came as a blow to some health groups that said this would put the treatment out of reach of thousands in poorer nations. The move comes at a time when India is facing increased pressure from the US to tighten its patent laws. In a report published in June this year, the United States Trade Representative expressed concerns over India’s intellectual property laws.

India has the largest number of pneumonia cases, and for Pfizer, this is a big gain. The decision also has international implications, as several poorer nations rely on India’s robust pharmaceutical industry to supply cheaper copies of medicines and vaccines.

FDA to start sharing full inspection reports with European regulators

This week, the European Commission (EC), the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) signed a new confidentiality commitment that allows the FDA to share non-public and commercially confidential information, including trade secret information relating to inspections with European regulators.

In March 2017, the United States and the European Union (EU) finally announced that they will be able to utilize each other’s good manufacturing practice (GMP) inspections of pharmaceutical manufacturing facilities.

The deal is expected to enable the US Food and Drug Administration (FDA) and the EU to avoid duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk.

This confidentiality commitment is a step in the ongoing implementation of the mutual recognition of inspections program.

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Image Credit : Difficult Times by Martin Belam is licensed under CC BY 2.0

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