"Herceptin," a type of "big" imported biological drug with outstanding efficacy, often makes people "love and hate." Its use for the treatment of serious diseases such as breast cancer has significant efficacy. Users will not experience the adverse reactions such as upsets and vomiting seen with conventional chemotherapy. However, the treatment costs are staggering. The selling price of a 440 mg preparation is as high as 23,000 yuan.

There is now good news for domestic patients: "Herceptin" and other large numbers of biological drugs will usher in a "patent lift" period next year. At that time, there will be domestic companies offering generic medicines with similar curative effect, and the price will be greatly reduced. Datamonitor data from the market research agency shows that in the six months after the generic drugs are market-oriented, prices will generally drop to about 20% of the original patented medicine prices.

Followers usher in a "retroactive" opportunity

Unlike "shanzhai" products, approved generic drugs are reasonable and legal.

Because it helps to reduce the cost of expensive patented medicines and save medical insurance expenses, it is related to social welfare and therefore has received extensive support from various governments. In 1984, the United States Congress passed the Drug Price Competition and Patent Term Compensation Act, officially opening the era of generic drugs.

The act has skillfully balanced the relationship between generic drugs and innovative drugs. It not only encourages the development of generic drugs, but also extends the period of patent protection to provide sufficient momentum for the development of new drugs. At present, the protection period for patents for innovative drugs is usually 20 years from the date of the patent application.

China has always been a big country in the use of generic drugs. In the nearly 100 billion U.S. dollar pharmaceutical market, the proportion of generic drugs is more than 90%, but it has fallen into the dilemma of high duplicity of “low-quality imitation” in the production of generic drugs.

According to data from the State Food and Drug Administration, among the new imitations and modified formulations that were filed in 2013, there were 1,039 approved drugs with 20 or more approval numbers, accounting for 42.8% of the total, which caused a waste of resources and to a certain extent. Excessive competition.

However, with chemical generic drugs falling from the peak of patent expiration in 2013, a new wave of overdue biopharmaceutical patents will come. The “white fever” competition may ease. Many experts hope that the high level of bio-pharmaceutical imitation can change the status of China's generic pharmaceutical industry and enable companies to find a differentiated survival path through technological upgrading.

Biosimilars are often compared to the crown of the high-tech industry. Compared with chemical generic drugs, they have high technical barriers and high investment thresholds. It takes a long time to study and requires more rigorous analytical tests to prove that it has a similar molecular structure to the reference product. It also requires more long-term clinical trials to prove that it has similar quality, safety, and effectiveness to the reference product, and research costs Up to hundreds of millions of dollars.

In addition, imitation companies must keep an eye on external trends, and may accidentally “step on the thunder” due to poor technology or improper application timing. Last year, Roche filed a lawsuit in the Indian market for breast cancer drugs jointly developed by Mailan and Pakang. The New Delhi High Court finally ruled that the two companies are prohibited from referring to Herceptin's production process and sales process when they promote generic drugs.

Imitation is not easy, but high profit margins still attract all competitors.

Recently, the State Food and Drug Administration accepted the clinical project of Sinopharm Co., Ltd. on "Herceptin" generics, which means that the domestic competition for generic drugs has escalated. Prior to this, Fosun Pharma, CITIC Guojian, etc. had all taken the lead in the drug application, and a "post-Herceptin" war was about to begin.

Join the reengineering of multinational companies' business processes

The battle for "Herceptin" is just a microcosm of the post-biological pharmacy era. According to the latest data from the international pharmaceutical industry research agency AMR, 10 influential biological drugs will lose patent protection in the next 4 years, and their sales will total 60 billion U.S. dollars.

With the gradual expiration of patents for heavy drugs, continuous increase in the cost of innovative drug research and development, and lower prices for medical reforms, multinational pharmaceutical companies are facing increasing operational pressure...

Multinational pharmaceutical giants such as Johnson & Johnson, Bayer, Roche, and Pfizer have to adjust the original vertical integration model to allow the business to return to the core. On the one hand, before the expiration of the patent, the company actively resists the competition of ordinary generic drugs by actively licensing generic drugs to cooperative companies, and continues to share the market harvest; at the same time, it gradually breaks down the research, development, production, and sales of innovative drugs. And outsource some of the projects.

The Asian market has relatively cheap factor prices and a huge market space. Institutions in India, China, and other markets tend to be their preferred partners.

Indian drug companies are undoubtedly the major stars in the emerging generic pharmaceutical market. Prior to 2000, they were mainly engaged in the production of low-cost APIs and pharmaceutical products. The exporting countries also focused on non-regulated markets such as Russia and Africa. However, before and after joining the international patent system in 2005, local large pharmaceutical companies quickly completed transformation and transformation. It now appears that many pharmaceutical companies in India were very far-sighted at that time, such as increasing investment in R&D, placing heavily on bio-pharmaceuticals, and gradually accumulating the advantages of R&D drug development.

For another example, it actively sought cross-border mergers and acquisitions opportunities and continued to integrate resources, and successfully entered mature markets such as the United States, Germany, and the United Kingdom. Last year, India’s total pharmaceutical exports amounted to between US$13 billion and US$14 billion, making it the second largest source of US generic imports.

“Chinese pharmaceutical companies are also faced with rare strategic opportunities. Actively cooperating with transnational giants and stepping up to learn related technologies, business and capital operation experience will help improve the future development space.” Zhuo Zhuo, Shennong Private Pharmaceuticals, observes the pharmaceutical industry all the year round. In his opinion, the constant adjustment of the internationalization road is the key to the success of Indian pharmaceutical companies and is worthy of reference by our pharmaceutical companies.

How should China's pharmaceutical companies participate in the world market? Luo Jiarong, an industry analyst at Shenyin Wanguo, summed up several “motivations”. Starting from the product side, companies in the future can choose to join the global production chain of multinational companies or obtain certification from overseas markets, and form high value-added exports in the form of preparations; the development of the business end can be completed through mergers and acquisitions of overseas companies or mergers and acquisitions; in the field of technology Project cooperation can speed up the acquisition of the latest R&D technology. Of course, companies that possess patented technology can also be authorized to expand their business; in terms of capital, overseas listing of companies can easily obtain the required capital services.

It is understood that some domestic start-up companies have recently taken action.

For example, Hisun Pharmaceutical and Pfizer established Haizheng Pfizer Pharmaceuticals Co., Ltd., which is an important attempt for cooperation between China and the United States in the pharmaceutical field. In May this year, the joint venture's Fuyang production base was officially put into production, and it is committed to the production of generic drugs under the two companies.

The announced cooperation program is very interesting. Pfizer and Hisun will inject 7 and more than 70 products respectively. The joint venture company will be responsible for the production and sales of these products, including Viagra's best-selling drug, Viagra, after the patent expires. Among them, about 20 products need to be completed by Haizheng Pfizer.

"The joint venture has built a good platform. With the new product line, it is not difficult for Hisun to complete the transition from a low-end API company to a pharmaceutical company. Next, how to use Pfizer's powerful marketing network to open the international market is the key." Say.