Roche, Pfizer and GSK will face the biggest patent cliff crisis? How can 2019 pharmaceutical tycoon break the situation when sales drop?

In 2019, many heavy-duty products from MNC are facing the huge challenge of patent cliff The challenge of generic drugs and biological similar drugs has been gradually clear, and even within the patent period, the price reduction pressure that may be faced by many original research manufacturers is a thorn in the throat In a word, the good days that have lasted for a long time may really come to an end With the heavy-duty products about to face the patent cliff, the global pharmaceutical giants will undoubtedly usher in a difficult period Although they have been trying their best to fight the expiration of heavy-duty original research patents and the squeeze of generic drugs on market share, for many original research drugs, the past glory is likely to change a lot in 2019 Pfizer's lerika, GSK's Adair, Roche's melowa, Geely's harvoni and many other global best sellers are likely to face new generic challenges this year Every company is trying new ways to resist the heavy economic losses brought by the patent cliff Fierce Pharma recently released a list of top 10 drugs that may face patent challenges in 2019 How will they deal with the challenges brought by the patent cliff in the next year? 1 meiluohua company: Roche's US sales in 2018: US $4.29 billion indications: blood cancer, rheumatoid arthritis prediction challenge period: Roche's Troika in the second half of 2019, at the same time, was threatened On the evening of February 25, the State Drug Administration issued the announcement that the first domestic bio similar drug was approved for listing Rituximab, a subsidiary of Fuhong Hanlin, was approved for listing on February 22 This is the first biologically similar drug in China, and Roche's rituximab has met a competitor for the first time in China In Europe, however, the company has been competing with biological analogues As early as early as 2017, Europe approved the first rituximab biosimilars According to Roche's financial report, last year, the sales volume of meiluohua in Europe has declined by 47% In the United States, the drug's sales in the United States reached 4.29 billion US dollars in 2018, a small increase of 4% But the competition storm of biological analogues will also spread from Europe to China and the United States At the end of November 2018, truxima, a bio generic drug developed by TIWA and celltrion, was approved by the U.S FDA as the first rituximab bio generic drug in the U.S market The drug is expected to go on sale in the middle of 2019 In the U.S market, Roche is targeted by bio similar drugs Whether in the United States or China, there is more than one market targeting rituximab In China, there are more than ten enterprises applying for similar drugs of rituximab In addition to Fuhong Hanlin, the products of four companies, including Xinda biology, Shenzhou cell engineering, Xikang biology and Haizheng pharmaceutical, have entered clinical phase III In the U.S market, Amgen, Pfizer and other companies have corresponding products in research and development In addition, similar biological drugs have been approved in Russia, India and other countries 2 Lerika: Pfizer's sales volume in the United States in 2018: US $3.5 billion indications: neural pain and fibromyalgia prediction challenge period: June 30 In 2018, Pfizer continued to occupy the top position of global pharmaceutical companies with us $53.6 billion revenue, an increase of 2% compared with 2017, and its annual net profit was US $11.15 billion, a decrease of 48% compared with 2017 Pfizer said new drugs, bioequivalent drugs and emerging markets, including China, were the main drivers of its performance Some of its well-known old drugs have been hit From the end of June to the patent period, lerica previously contributed nearly 10% of Pfizer's sales Its sales increased from $291 million in 2015 to $5.309 billion in 2017, and has maintained a high growth since its listing In order to extend the exclusive period, Pfizer has previously submitted a daily extended release version of Lyrica to the US FDA for the treatment of pain caused by herpes zoster or diabetic peripheral neuropathy In addition, we are also working on the exclusive right of Pediatrics to extend its patent protection for six months According to the data provided by evaluate, the drug has been used in the United States for more than 30 billion dollars since it was first approved by FDA But when the patent expires, Pfizer may lose billions of dollars In the face of the expiration of the market monopoly period of lerica, Pfizer is also stepping up its development in the field of anti-tumor For example, the approved breast cancer treatment drug ibrance in 2015 has a rapid growth in sales performance in three years since its listing In 2017, the sales volume has exceeded US $3.1 billion In 2018, Pfizer's sales volume keeps a positive growth thanks to the substantial growth of the drug 3 Herceptin company: Roche's 2018 U.S sales: US $2.008 billion indications: breast cancer, gastric cancer and other forecast challenges: in the second half of 2019, Roche will be threatened by more than one drug in 2019, including rituximab, and its monoclonal antibody drugs Herceptin and avidin will be impacted by similar biological drugs Herceptin, approved in 1998, has become the main drug for the treatment of HER2 positive breast cancer, with $2.9 billion in use in the United States last year The drug will pass a key patent protection period on June 18 At present, Herceptin is facing less competition than rituximab According to Roche financial report, Herceptin's global sales in 2018 were $6.929 billion, an increase of 1% year on year Roche said in the financial report that the growth was mainly driven by the U.S and China markets, while in Europe and Japan, sales of Herceptin fell 16% year-on-year due to the competition of bio similar drugs Celltrion, Samsung and mylan are all following up on Herceptin's biological analogues Onstruzant of South Korea's Samsung bioepis was recently approved by the FDA, which is the third Herceptin analogue approved by the FDA Ontruzan was approved by the European Commission in November 2017 and has been listed in more and more European countries since then The FDA accepted the approval of ontruzan in December 2017 Due to the great resistance in the U.S market, ontruzan was not approved until January 18 this year It is expected that in the second half of this year, in the face of patent expiration, and the listing of bio similar drugs in the two major contribution areas of China and the United States, the small growth trend of Herceptin sales will go At present, many domestic pharmaceutical enterprises, including Fosun Pharmaceutical, are laying out related biological analogues Avidin: Roche's 2018 U.S sales: US $2.9 billion indications: rectal cancer, non squamous non-small cell lung cancer and other forecast challenges: in the second half of 2019, Roche's last carriage, the situation faced by avidin may not be as urgent as Herceptin and Merrill In the United States, Roche may be able to slow down the marketing process of Avastin Some analysts believe that for avidin, which is plagued by legal disputes, the similar products may not be able to enter the market by 2020 Amgen's avidin biosimilars will be the drug's main competitors, but due to legal disputes, the drug is less likely to go on the market in 2019 However, the drug is about to face fierce competition in the European Union with the recently licensed biological analogue mvasi approved by Amgen / Elgin, the first EU approved generic version of bevacizumab Pfizer, Samsung and celltrion are all laying out avidin's biological analogues In China, CDE recently officially accepted the listing application of Cinda's imitations Including avidin, Roche's three anti-cancer drugs may face a global price war At the same time, Roche is also looking for new growth points in the field of gene therapy through M & A 5 epclusa and harvoni: Geely Tech's U.S sales in 2018: $1.736 billion indications: hepatitis C forecast challenge period: January Epclusa and harvoni are Geely Tech's hepatitis C drugs, also known as the "third generation" and "second generation" Geely's revenue in 2018 reached US $22.127 billion, down 15.2% In sharp contrast to the 12.4% growth of AIDS products, the proportion and growth rate of hepatitis C drugs are not ideal The income of the third generation of Jilin Province was USD 1.966 billion, down 44%, and that of the second generation was USD 1.222 billion, down 72% In 2014, two major hepatitis C drugs sovaldi and harvoni pushed Gilead to the top 10 pharmaceutical companies in the world with their strong explosive power, but the pressure of drug price, competitive products, medical insurance payment and market ceiling came along From the data point of view, sovaldi and harvoni brought a total of US $12.41 billion of sales revenue to Gilead in 2014, and in 2015, sovaldi's sales decreased by US $5 billion, but harvoni exploded, and the two magic drugs brought us $19.14 billion of revenue to Gilead In 2016, harvoni and sovaldi jointly staged a great recession, with revenue falling back to 13 billion yuan, while in 2018, it has declined to more than 3 billion dollars, a significant decline In 2019, the recession will be hard to change 6 sensipar company: Amgen's sales volume in 2018: US $1.43 billion indications: calcium mimetic forecast challenge period: Amgen's patent period of sensipar has expired in March 2018, but due to the difficulty of copying, currently there are few generic drugs on the market However, the FDA has approved several imitations of sensipar, and it is likely that sensipar will need to challenge a full range of imitations at a certain stage after these imitations are launched In the face of the impact, Amgen has started to defend against this, for example, filing patent lawsuits against some generic pharmaceutical manufacturers to deal with patent disputes; in addition, Amgen also has formula patents that only expire in 2026 from sensipar, preparing for the future market war For example, TIWA's share price soared after the introduction of its imitations, but at present, Amgen and TIWA have reached a settlement, and TIWA's imitations won't be listed before 2021 Another analyst pointed out that sensipar's generic is 40% likely to launch in the fourth quarter of 2019 or later In addition to sensipar, Anjin's neulasta and Epogen also face challenges from biological analogues, and enri's market, which has the highest sales share, is also under threat 7 advair: GSK's U.S sales in 2018: $1.42 billion indications: asthma and chronic obstructive pulmonary disease prediction challenge period: February this year, medot's Godot was approved by FDA, which also means that advair, GSK's respiratory product, ushered in a new wave of generic impact Although advair lost patent protection in 2010, its Diskus inhaler technology is difficult to replicate, and many generic drugs have failed before, and the patent of advair expired in 2016 Advair peaked in 2013 with global sales of £ 5.27 billion and sales of £ 24 in 2018 A price war ensued immediately after the launch of mindot, which was launched at 30% of advair's list price Analysts point out that despite some discounts, Godot is actually 20% cheaper than advair In addition to mylan, Novartis' imitations are also expected to be launched in 2020 8 restasis: Elkem 2018 US sales: $1.2 billion indications