Market Place
PhRMA publishes list of US cancer drug pipeline; Biocon-Mylan’s Neulasta biosim bags FDA nod
This week in Phispers, Biocon–Mylan scored a big win by getting the FDA nod for its biosimilar to Amgen’s Neulasta. There is also news on pathbreaking findings on cancer drugs, and a new report that says 1,120 oncology drugs are in the pipeline in the US alone. AstraZeneca says it will reveal payments it made to doctors worldwide in order to win patients’ trust. The FDA announced new policies to reduce exploitation of the REMS program by drug firms in order to block timely entry of generics. And in compliance news, the FDA issued a warning letter to IDT Australia over data-integrity concerns.
Big win for Biocon-Mylan as FDA approves Neulasta biosimilar
This was a big week for Biocon-Mylan. The US Food and Drug Administration (FDA) approved Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta (pegfilgrastim). Neulasta is used to decrease the chance of infection in patients with non-myeloid (non-bone marrow) cancer.
Fulphila is the second biosimilar developed by Biocon-Mylan to bag an FDA nod after Trastuzumab in late 2017. Mylan anticipates launching Fulphila in the coming weeks. Neulasta had US sales of US$ 4.2 billion for the 12 months ending March 31, 2018.
Just last month, Biocon’s Bengaluru plant had received a Form 483 from the FDA with seven observations. Fulphila will be manufactured at the same plant. The FDA nod indicates that Biocon’s response to the observations was satisfactory and the plant is cleared for future exports.
Unlike other products for which biosimilars have been approved by the US and European regulators, Amgen’s Neulasta has not been an easy product to bag approval.
Sandoz — Biocon’s competitor for a Neulasta biosimilar — withdrew its European application in January 2017 after the emergence of clinical equivalency concerns, along with concerns over lack of a GMP certificate for the medicine’s manufacturing site. Sandoz’s European withdrawal follows a rejection by the FDA of Sandoz’s application for its Neulasta biosimilar in July 2016. In October 2017, Sandoz announced that its Neulasta biosimilar had been accepted for regulatory review in Europe and it is expected to re-file with the FDA in 2019.
In June 2017, Coherus BioSciences announced the FDA denied approval of its Neulasta biosimilar. Coherus resubmitted their application, which was accepted by FDA and a decision is expected by October/November of 2018.
Other biosimilar makers have encountered problems as well, such as Hungary’s Gedeon Richter that withdrew its application after the EMA “was concerned that study results had not shown that (the proposed biosimilar) was handled by the body in the same way as the reference medicine Neulasta.”
The good news for Biocon-Mylan didn’t end with Fulphila. The FDA rejected Amgen and its partner Allergan’s biosimilar application for their Herceptin copycat — ABP 980. In December last year, the FDA had approved Mylan-Biocon’s biosimilar to Herceptin — Ogivri (trastuzumab-dkst). Ogivri has been approved for all indications included in the label of the reference product. Therefore, the rejection of ABP 980 reduces competition for Ogivri.
Meanwhile, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has offered a positive opinion on four biosimilars, and has recommended granting marketing authorization for these products.
The four biosimilars that received the CHMP’s recommendation are three adalimumab biosimilars from Novartis and a trastuzumab biosimilar from Pfizer. The adalimumab biosimilars reference AbbVie’s Humira (adalimumab) while the trastuzumab biosimilar references Roche’s Herceptin (trastuzumab).
PhRMA publishes list of US cancer drug
pipeline, compilations of ASCO
Every year, the meeting of the American Society of Clinical Oncology (ASCO) draws 45,000 doctors, researchers, and drug company executives to Chicago where they look at a deluge of data. This year was no different, and there were several pathbreaking findings.
For instance, findings reveal that Merck’s Keytruda has unprecedented efficacy in lung cancer, especially in squamous cell non-small cell lung cancer, the last big market for metastatic lung cancer. Similarly, Roche displayed that adding its Tecentriq to chemotherapy lowered the risk of cancer progressing by 30 percent, but did not impact survival.
Similarly, Merck’s data showed a 40 percent reduction in progression and a 36 percent reduction in the risk of death when Keytruda was added to chemo. And now, analysts expect Keytruda to hit annual sales of US$ 12 billion in several years.
ASCO’s compilation also had findings from personalized medicine companies such as Genomic Health and Bluebird Bio’s CAR-T therapy against multiple myeloma. However, the biggest surprise at ASCO came from the diabetes drug metformin. In a small randomized trial of 140 patients conducted in Mexico City, adding metformin to drugs for lung cancer patients whose tumors had mutations in a gene called EGFR seemed to slow disease progression and survival. While the finding is fascinating, larger trials are required for confirming this.
PhRMA’s new report, on the other hand, has counted each cancer drug in the US pipeline. According to PhRMA’s report, this year in the US alone, there are 1,120 oncology drugs in the clinic so far — a massive increase from previous years.
In 2015, PhRMA had counted 836 cancer therapies. The organization only counted drugs already in the clinic or awaiting review from the FDA. That means there’s a significant backlog of therapies in preclinical development, awaiting the various phases of clinical trials.
Of the 1,120 therapies in the clinic, nearly 300 are immuno-oncology drugs or vaccines.
PhRMA is upbeat about the pipeline. It says 85 percent of cancer drugs in development are first-in-class treatments. And the organization is quick to point out that the need for new cancer treatments is still crucial. More than 1.7 million new cases of cancer are expected to develop in the US alone in 2018.
To win patients’ trust, AstraZeneca says it will reveal doctor payments worldwide
Last month, a news report narrated a 2015 episode of a pharmaceutical sales representative in New Jersey who wanted to increase her sales of an opioid painkiller — Subsys — but was worried that she was selling an addictive and dangerous product.
When the rep (referred to as MS) voiced her concerns to her manager, she was told that Subsys patients were “already addicts”. To boost sales, the manager allegedly advised MS to “behave more sexually toward pain-management physicians, to stroke their hands while literally begging for prescriptions,” and to ask for the prescriptions as a “favor.”
In an industry where sales representatives have been asked to “behave more sexually”, AstraZeneca’s CEO Pascal Soriot has said “(there was) no reason” for the company to “not disclose” its payments to healthcare professionals.
Pharmaceutical companies’ payments to doctors have, for long, raised concerns about prescription bias and have triggered bribery investigations.
Therefore, AstraZeneca has taken the lead in order to win patients' trust and bring about transparency. It plans to disclose all its doctor payments, even in regions where it's not required. Several countries, such as the US, require those disclosures under local regulations.
AstraZeneca and its subsidiaries currently report payments to healthcare professionals and organizations in the US, Europe, Australia and Japan, among others, which account for 90 percent of its total payments. It intends to add disclosures in another 11 countries by 2019-end.
However, getting all the information together won’t be easy. The company is active in more than 100 countries, with about 34,600 employees engaged in commercial activities in 2017-end. Most countries don’t require the data and therefore don’t have platforms to collect them. Even where there is a government database, no single regulatory body asks drugmakers to disclose payments made outside its jurisdiction.
In its annual report, AstraZeneca has self-identified six confirmed breaches of external sales and marketing regulations or codes.
FDA
announces new policies to reduce exploitation of REMS program by drug firms
In a statement, the FDA Commissioner Scott Gottlieb recently spoke about how brand drug makers are using the Risk Evaluation and Mitigation Strategy (REMS) program to block the timely entry of generic drugs in the market.
The FDA chief addressed the back-end tactics employed by pharma companies that can delay the entry of generics into the market.
“We have seen REMS requirements be exploited in two ways. One occurs at the front end of the drug development process, when generic drugs are being developed,” Gottlieb wrote. “The other occurs at the back end of the process, after necessary testing has been completed when a generic drug seeks approval and market entry.”
“The REMS shouldn’t become a tool that drug companies can use to delay or block competition from generic products or hinder their ability to enter the market,” he added.
The FDA’s first draft guidance details the principles and recommendations for the development of these programs. The goal is to improve the clarity and efficiency for developing shared system REMS, which will enable timelier market entry for products that are part of these REMS.
The agency’s second draft guidance — Waivers of the Single, Shared System REMS Requirement — defines when and how the FDA will deem it appropriate to waive the single, shared system requirement, as well as how applicants can request the waiver.
FDA
issues warning letter to IDT Australia over data-integrity concerns
An FDA inspection at the active pharmaceutical ingredients (API) and finished pharmaceuticals manufacturing operations of IDT Australia Limited uncovered ‘significant violations’ and data-integrity concerns. The firm has been issued a warning letter.
The inspection conducted during December 4 and 8, 2017 found that the IDT Australia’s quality unit released API used to manufacture sterile finished drug products in the United States despite a failing microbial count. In the case of the firm’s finished pharmaceutical product testing, the FDA found that the firm was misreporting microbial test results as the “sample collection and test methods could have masked failing microbial results”.
While reviewing the laboratory records, the FDA uncovered that the firm “failed to report non-conforming test results on multiple occasions in multiple parts” of its operations.
The warning letter also mentions that the “quality unit failed to review high performance liquid chromatography (HPLC) assay data for release and stability” of drug product and while reviewing the HPLC electronic data, the FDA investigator discovered at least 100 “test” injections.
IDT Australia’s laboratory supervisors did not review these injections prior to submitting the data packages for approval.
The warning letter also states that IDT’s analysts performed manual integration of chromatograms without instructions and that the firm did not have procedures for reviewing audit trails or electronic data for the Fourier-transform infrared spectroscopy or ultraviolet systems.
The FDA also issued a warning letter to Kolmar Korea Co Limited, raising concerns over the firm’s lack of thorough investigations into out-of-specification (OOS) assay test results for finished pharmaceutical creams sold over-the-counter in the United States.
At Kolmar, the FDA investigator also observed documents and records, including batch production records, certificates of analysis, and laboratory worksheets that were torn and discarded without documented quality unit approval.
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